Minaris Regenerative Medicine GmbH
Associate Director, Facilities & Engineering
Minaris Regenerative Medicine GmbH, Allendale, New Jersey, us, 07401
Allendale, 75 Commerce Drive, Allendale, New Jersey, United States of America
Job Description Posted Monday, September 22, 2025 at 5:00 AM
Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market.
At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life‑saving therapies and make a lasting difference. If you're passionate about advancing cutting‑edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time.
Position Summary The Associate Director, Facilities & Engineering is responsible for the strategic leadership and operational management of facility operations, engineering systems, and capital projects to support GMP and non‑GMP operations within a cell and gene therapy contract development and manufacturing organization (CDMO). This role ensures the reliable, compliant, safe, and efficient operation of facility services, utilities, engineering systems, and equipment in accordance with applicable regulatory requirements and internal quality standards.
This position oversees the execution of preventative and corrective maintenance programs, metrology, utility systems (HVAC, building management systems, clean utilities such as WFI, clean steam, compressed air, and water systems), and process equipment. The Associate Director is responsible for managing and optimizing both routine facility operations and technical engineering activities, including the development and implementation of an Asset Management Program to support commercial readiness, quality assurance, and regulatory compliance.
Additionally, the role provides strategic oversight of capital planning and execution, including the development of business processes and systems to support engineering and facilities initiatives. This includes defining, planning, and delivering capital and maintenance projects, managing associated budgets and timelines, and negotiating with external vendors and contractors.
The Associate Director, Facilities & Engineering ensures compliance across all engineering, asset management, and facilities systems, and supports continuous improvement efforts across all related functions.
Essential Functions and Responsibilities
Provide strategic oversight and direction to implement and maintain a comprehensive Asset Management Program across the site. This includes defining the long‑term vision and roadmap, setting performance metrics, aligning cross‑functional stakeholders, and ensuring integration with overall business and compliance objectives.
Oversee the execution of the site’s Preventive Maintenance and Calibration Programs, ensuring that all critical utilities, systems, and equipment are maintained in a state of control and compliance with regulatory expectations and company standards.
Lead the development, planning, and execution of capital budgets, including oversight of key capital projects to ensure timely delivery, adherence to approved scope, and cost‑effectiveness. Ensure that projects meet performance goals and regulatory requirements.
Drive reliability and continuous improvement initiatives related to facilities operations, maintenance practices, utilities, and engineering systems, with a focus on enhancing operational performance, equipment uptime, and compliance.
Provide strategic guidance for long‑term capital planning, including facility expansion, capacity optimisation, and infrastructure improvements to support future growth and evolving business needs.
Manage internal and external resources for metrology, calibration, repair, preventive maintenance, and installation activities. Oversee contractor performance and ensure alignment with site policies and safety protocols.
Collaborate cross‑functionally in the execution and enhancement of capital project management processes, including Engineering Design standards, RFPs, Design Qualifications (DQ), Commissioning, and Equipment Turnover Packages (ETOP). Promote best practices across departments and projects.
Maintain ongoing communication with contractors, internal stakeholders (Operations, Validation, QA/QC, IT, MSAT, Materials Management), and leadership to ensure alignment of engineering and facilities operations with organizational goals.
Provide leadership in the development and implementation of Site Master Plans, including evaluating facility designs for compliance with EHS, regulatory, and operational requirements, and integrating innovative and sustainable solutions.
Oversee site security operations and infrastructure to ensure the physical security of personnel, assets, and operations. Coordinate with internal stakeholders to assess risk and implement necessary safeguards.
Define, implement, and support systems, processes, and standards that enhance capital effectiveness, operational consistency, energy efficiency, ergonomic design, and regulatory compliance across all engineering and facilities functions.
Ensure that all Facilities, Engineering, and Equipment Quality Systems are compliant with regulatory requirements, company policies, and industry standards. Lead and support quality investigations, CAPAs, Change Controls, and ensure timely resolution of quality commitments.
Lead departmental planning activities, including budget development, organizational structure, staffing strategies, training programs, and performance management. Recruit, train, and mentor staff to build a high‑performing team and drive continuous improvement in departmental performance.
Leadership Responsibility
Determines staffing needs and leads recruitment, interviewing, hiring, and onboarding.
Provides day‑to‑day oversight in alignment with organizational policies, GMP regulations, and facilities & engineering procedures.
Coaches, mentors, and develops staff; supports onboarding and drives career development planning and training opportunities.
Empowers team members by delegating responsibilities, setting clear expectations, and providing consistent feedback and accountability.
Fosters a culture of teamwork, collaboration, and problem‑solving, addresses conflicts promptly and constructively.
Promotes a workplace culture aligned with the organization’s mission, vision, and core values.
Leads performance management activities, including goal setting, performance reviews, and individual development planning.
Effectively communicates key information via team meetings, one‑on‑one discussions, and written communication.
Knowledge, Skills & Ability
Adequate knowledge of facilities systems, utilities, and pharmaceutical equipment operation, including principles of maintenance, metrology, and instrumentation troubleshooting and repair.
Demonstrated leadership experience in managing facilities and engineering teams, with a strong track record of delivering results in maintenance, equipment reliability, and infrastructure operations.
Strong technical knowledge of calibration, metrology, mechanical, electrical, HVAC, plumbing, safety systems, and building management/control systems. Hands‑on engineering or maintenance experience required.
In‑depth knowledge of cGMP regulations, aseptic operations, quality systems, and regulatory compliance standards. Familiarity with applicable CFRs and industry best practices, including Recognized and Generally Accepted Good Engineering Practices (RAGAGEP) and global regulatory requirements (e.g., 21 CFR).
Applied knowledge of preventive and predictive maintenance strategies, Reliability‑Centered Maintenance (RCM), and performance standards for manufacturing equipment and facilities.
Proficiency with reliability methodologies and tools such as Root Cause Analysis (RCA), Failure Mode and Effects Analysis (FMEA), structured problem‑solving, Lean, and Six Sigma.
Experience managing and executing capital projects, site assessments, and long‑term planning efforts, including preparation of technical documentation and regulatory deliverables.
Familiarity with sustainability initiatives and energy management programs aimed at driving efficient, cost‑effective, and environmentally responsible operation of facilities and equipment.
Strong business and financial acumen, with an understanding of budgeting, forecasting, and cost control principles, as well as facility and equipment lifecycle management.
Advanced proficiency in computer systems including CMMS (e.g., Maximo), Microsoft Project, Excel, Word, Visio, PowerPoint, and familiarity with AutoCAD and Building Information Modeling (BIM) software.
Proven ability to work autonomously in a fast‑paced, entrepreneurial environment with strong business acumen, strategic thinking, and operational execution.
Excellent interpersonal skills with the ability to navigate ambiguity, build effective cross‑functional relationships, and collaborate with diverse teams to achieve shared goals.
Strong organisational and project management capabilities to lead complex initiatives, maintain compliance, and ensure timely execution of maintenance and capital projects.
Effective verbal and written communication skills with the ability to influence, present, and communicate clearly across all levels of the organization, including executive leadership and operational teams.
High level of flexibility and adaptability to accommodate company growth, evolving responsibilities, and organisational transformation.
Competence in meeting facilitation, cross‑functional teamwork, and conflict resolution in a matrixed environment.
Demonstrated diligence and accountability in meeting deadlines, fulfilling commitments, and delivering quality outcomes.
Strong desire for continuous learning and professional development within the organization.
Education & Experience
Bachelor’s degree in engineering, Facilities Management, or a related STEM field required. Advanced degree or professional certification preferred.
A minimum of 10 years of progressive experience in Facilities, Engineering, Maintenance, or Metrology roles within a GMP‑regulated environment (Pharmaceutical, Biotechnology, Life Sciences, or Medical Device industry preferred).
Disclaimer The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
The estimated base salary range for each open position based in the United States of America is included for all our current openings. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) as part of the compensation package. Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.
Allendale, 75 Commerce Drive, Allendale, New Jersey, United States of America
#J-18808-Ljbffr
Job Description Posted Monday, September 22, 2025 at 5:00 AM
Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market.
At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life‑saving therapies and make a lasting difference. If you're passionate about advancing cutting‑edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time.
Position Summary The Associate Director, Facilities & Engineering is responsible for the strategic leadership and operational management of facility operations, engineering systems, and capital projects to support GMP and non‑GMP operations within a cell and gene therapy contract development and manufacturing organization (CDMO). This role ensures the reliable, compliant, safe, and efficient operation of facility services, utilities, engineering systems, and equipment in accordance with applicable regulatory requirements and internal quality standards.
This position oversees the execution of preventative and corrective maintenance programs, metrology, utility systems (HVAC, building management systems, clean utilities such as WFI, clean steam, compressed air, and water systems), and process equipment. The Associate Director is responsible for managing and optimizing both routine facility operations and technical engineering activities, including the development and implementation of an Asset Management Program to support commercial readiness, quality assurance, and regulatory compliance.
Additionally, the role provides strategic oversight of capital planning and execution, including the development of business processes and systems to support engineering and facilities initiatives. This includes defining, planning, and delivering capital and maintenance projects, managing associated budgets and timelines, and negotiating with external vendors and contractors.
The Associate Director, Facilities & Engineering ensures compliance across all engineering, asset management, and facilities systems, and supports continuous improvement efforts across all related functions.
Essential Functions and Responsibilities
Provide strategic oversight and direction to implement and maintain a comprehensive Asset Management Program across the site. This includes defining the long‑term vision and roadmap, setting performance metrics, aligning cross‑functional stakeholders, and ensuring integration with overall business and compliance objectives.
Oversee the execution of the site’s Preventive Maintenance and Calibration Programs, ensuring that all critical utilities, systems, and equipment are maintained in a state of control and compliance with regulatory expectations and company standards.
Lead the development, planning, and execution of capital budgets, including oversight of key capital projects to ensure timely delivery, adherence to approved scope, and cost‑effectiveness. Ensure that projects meet performance goals and regulatory requirements.
Drive reliability and continuous improvement initiatives related to facilities operations, maintenance practices, utilities, and engineering systems, with a focus on enhancing operational performance, equipment uptime, and compliance.
Provide strategic guidance for long‑term capital planning, including facility expansion, capacity optimisation, and infrastructure improvements to support future growth and evolving business needs.
Manage internal and external resources for metrology, calibration, repair, preventive maintenance, and installation activities. Oversee contractor performance and ensure alignment with site policies and safety protocols.
Collaborate cross‑functionally in the execution and enhancement of capital project management processes, including Engineering Design standards, RFPs, Design Qualifications (DQ), Commissioning, and Equipment Turnover Packages (ETOP). Promote best practices across departments and projects.
Maintain ongoing communication with contractors, internal stakeholders (Operations, Validation, QA/QC, IT, MSAT, Materials Management), and leadership to ensure alignment of engineering and facilities operations with organizational goals.
Provide leadership in the development and implementation of Site Master Plans, including evaluating facility designs for compliance with EHS, regulatory, and operational requirements, and integrating innovative and sustainable solutions.
Oversee site security operations and infrastructure to ensure the physical security of personnel, assets, and operations. Coordinate with internal stakeholders to assess risk and implement necessary safeguards.
Define, implement, and support systems, processes, and standards that enhance capital effectiveness, operational consistency, energy efficiency, ergonomic design, and regulatory compliance across all engineering and facilities functions.
Ensure that all Facilities, Engineering, and Equipment Quality Systems are compliant with regulatory requirements, company policies, and industry standards. Lead and support quality investigations, CAPAs, Change Controls, and ensure timely resolution of quality commitments.
Lead departmental planning activities, including budget development, organizational structure, staffing strategies, training programs, and performance management. Recruit, train, and mentor staff to build a high‑performing team and drive continuous improvement in departmental performance.
Leadership Responsibility
Determines staffing needs and leads recruitment, interviewing, hiring, and onboarding.
Provides day‑to‑day oversight in alignment with organizational policies, GMP regulations, and facilities & engineering procedures.
Coaches, mentors, and develops staff; supports onboarding and drives career development planning and training opportunities.
Empowers team members by delegating responsibilities, setting clear expectations, and providing consistent feedback and accountability.
Fosters a culture of teamwork, collaboration, and problem‑solving, addresses conflicts promptly and constructively.
Promotes a workplace culture aligned with the organization’s mission, vision, and core values.
Leads performance management activities, including goal setting, performance reviews, and individual development planning.
Effectively communicates key information via team meetings, one‑on‑one discussions, and written communication.
Knowledge, Skills & Ability
Adequate knowledge of facilities systems, utilities, and pharmaceutical equipment operation, including principles of maintenance, metrology, and instrumentation troubleshooting and repair.
Demonstrated leadership experience in managing facilities and engineering teams, with a strong track record of delivering results in maintenance, equipment reliability, and infrastructure operations.
Strong technical knowledge of calibration, metrology, mechanical, electrical, HVAC, plumbing, safety systems, and building management/control systems. Hands‑on engineering or maintenance experience required.
In‑depth knowledge of cGMP regulations, aseptic operations, quality systems, and regulatory compliance standards. Familiarity with applicable CFRs and industry best practices, including Recognized and Generally Accepted Good Engineering Practices (RAGAGEP) and global regulatory requirements (e.g., 21 CFR).
Applied knowledge of preventive and predictive maintenance strategies, Reliability‑Centered Maintenance (RCM), and performance standards for manufacturing equipment and facilities.
Proficiency with reliability methodologies and tools such as Root Cause Analysis (RCA), Failure Mode and Effects Analysis (FMEA), structured problem‑solving, Lean, and Six Sigma.
Experience managing and executing capital projects, site assessments, and long‑term planning efforts, including preparation of technical documentation and regulatory deliverables.
Familiarity with sustainability initiatives and energy management programs aimed at driving efficient, cost‑effective, and environmentally responsible operation of facilities and equipment.
Strong business and financial acumen, with an understanding of budgeting, forecasting, and cost control principles, as well as facility and equipment lifecycle management.
Advanced proficiency in computer systems including CMMS (e.g., Maximo), Microsoft Project, Excel, Word, Visio, PowerPoint, and familiarity with AutoCAD and Building Information Modeling (BIM) software.
Proven ability to work autonomously in a fast‑paced, entrepreneurial environment with strong business acumen, strategic thinking, and operational execution.
Excellent interpersonal skills with the ability to navigate ambiguity, build effective cross‑functional relationships, and collaborate with diverse teams to achieve shared goals.
Strong organisational and project management capabilities to lead complex initiatives, maintain compliance, and ensure timely execution of maintenance and capital projects.
Effective verbal and written communication skills with the ability to influence, present, and communicate clearly across all levels of the organization, including executive leadership and operational teams.
High level of flexibility and adaptability to accommodate company growth, evolving responsibilities, and organisational transformation.
Competence in meeting facilitation, cross‑functional teamwork, and conflict resolution in a matrixed environment.
Demonstrated diligence and accountability in meeting deadlines, fulfilling commitments, and delivering quality outcomes.
Strong desire for continuous learning and professional development within the organization.
Education & Experience
Bachelor’s degree in engineering, Facilities Management, or a related STEM field required. Advanced degree or professional certification preferred.
A minimum of 10 years of progressive experience in Facilities, Engineering, Maintenance, or Metrology roles within a GMP‑regulated environment (Pharmaceutical, Biotechnology, Life Sciences, or Medical Device industry preferred).
Disclaimer The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
The estimated base salary range for each open position based in the United States of America is included for all our current openings. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) as part of the compensation package. Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.
Allendale, 75 Commerce Drive, Allendale, New Jersey, United States of America
#J-18808-Ljbffr