BioSpace
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Staff Process Engineer
role at
BioSpace
Syner-G BioPharma Group is a science‑led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post‑market, along with operational strategy and support. With a global team of 400 employees across North America and India, our goal is to help our partners navigate the complexities of product development and accelerate their journey to market.
Position Overview We are seeking a Staff Process Engineer / Project Engineer with deep expertise in manufacturing and packaging equipment, process engineering, and project execution. This hybrid role combines technical leadership in process engineering with project management responsibilities to drive compliance, efficiency, and innovation across manufacturing operations.
Key Responsibilities
Review equipment drawings and specifications to ensure alignment with process requirements and regulatory standards.
Create, review, and approve Turnover Packages (TOPs) and other commissioning documentation.
Verify Owner‑Furnished Contractor‑Installed (OFCI) equipment lists for accuracy and completeness.
Scope, select, and review transmitters, sensors, and instrumentation for manufacturing and packaging equipment.
Support equipment commissioning and qualification activities, including FAT/SAT and IQ/OQ documentation.
Provide process engineering input during design reviews, equipment selection, and installation phases.
Maintain and enhance manufacturing and packaging quality systems to ensure compliance with FDA, EMA, and related regulations.
Develop and improve SOPs, work instructions, and quality documentation related to manufacturing and packaging processes with a focus on lifecycle management.
Lead and implement change management strategies for manufacturing and packaging, supporting product lifecycle changes and minimizing operational impact.
Manage and review equipment change requests to ensure timely, accurate, and compliant updates.
Collaborate with regulatory, quality, and manufacturing teams to evaluate and execute changes, supporting a first‑time‑right approach.
Plan, execute, and oversee manufacturing and packaging projects from concept through implementation, ensuring alignment with product launch timelines and regulatory requirements.
Develop project scopes, timelines, and resource plans to ensure seamless coordination with cross‑functional teams.
Identify project risks and implement risk mitigation strategies including process improvements, supply chain redundancy, and regulatory compliance.
Analyze existing manufacturing and packaging workflows, identify opportunities for process improvements, and implement best practices to increase efficiency and reduce risk.
Drive continuous improvement initiatives to streamline manufacturing and packaging processes, enhancing compliance, productivity, and cost‑effectiveness.
Provide technical expertise and troubleshooting support for manufacturing and packaging issues, including root cause analysis and corrective action planning.
Support manufacturing operations including issue trending and improvement projects.
Ensure that all manufacturing and packaging specifications meet regulatory/process standards.
Serve as a key liaison between quality assurance, manufacturing, regulatory affairs, and supply chain to align manufacturing strategies with overall business objectives.
Support product launches, updates, and regulatory requirements by coordinating with cross‑functional teams to achieve timely and compliant product releases.
Act as a product manager for manufacturing and packaging equipment, ensuring that product development aligns with market needs and regulatory standards.
Monitor market trends and competitor products to identify opportunities for innovation and improvement in manufacturing and packaging equipment.
Develop and maintain product roadmaps, ensuring alignment with business goals and customer needs.
Collaborate with marketing and sales teams to develop product positioning and messaging that differentiates our products in the market.
Qualifications And Requirements
Education: Bachelor’s degree in Engineering (Mechanical, Chemical, or Process), Regulatory Affairs, or a related field.
Minimum of 7–11 years of experience in pharmaceutical manufacturing and packaging, with specific expertise in process engineering and equipment management.
Strong background in equipment commissioning, instrumentation, and process validation.
Deep understanding of cGMP, FDA, EMA, and USP guidelines relevant to manufacturing and packaging. Proficiency with quality systems including change control and quality events.
Demonstrated success in managing multiple projects in parallel.
Knowledge, Skills, and Abilities
Excellent communication skills with the ability to work effectively across departments and influence stakeholders.
Strong project management skills, with the ability to manage multiple projects simultaneously.
Strong leadership and team management abilities.
Detail‑oriented with strong analytical and problem‑solving capabilities.
Ability to work in a fast‑paced, dynamic environment.
Essential Functions
Regular use of computer keyboard and mouse; reaching with hands and arms; talking and listening.
Frequent walking and sitting; occasional lifting of objects up to 25 pounds.
Occasional standing, stooping, or kneeling.
Specific vision abilities including close vision and the ability to adjust focus.
Moderate noise level, indoor temperate environment, and bright lighting typical of an office setting.
Total Rewards Program We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company‑paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more suitable, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.
Applicants must have current work authorization when accepting a position at Syner‑G. Currently, Syner‑G is unable to sponsor or take over sponsorship of an employment Visa at this time.
Legal Statement Syner‑G BioPharma Group is proud to be an Equal Employment Opportunity and affirmative action employer. All employment decisions, including recruitment, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to race, color, creed, religion, sex, pregnancy, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected status.
Syner‑G BioPharma is an E‑Verify employer.
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Staff Process Engineer
role at
BioSpace
Syner-G BioPharma Group is a science‑led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post‑market, along with operational strategy and support. With a global team of 400 employees across North America and India, our goal is to help our partners navigate the complexities of product development and accelerate their journey to market.
Position Overview We are seeking a Staff Process Engineer / Project Engineer with deep expertise in manufacturing and packaging equipment, process engineering, and project execution. This hybrid role combines technical leadership in process engineering with project management responsibilities to drive compliance, efficiency, and innovation across manufacturing operations.
Key Responsibilities
Review equipment drawings and specifications to ensure alignment with process requirements and regulatory standards.
Create, review, and approve Turnover Packages (TOPs) and other commissioning documentation.
Verify Owner‑Furnished Contractor‑Installed (OFCI) equipment lists for accuracy and completeness.
Scope, select, and review transmitters, sensors, and instrumentation for manufacturing and packaging equipment.
Support equipment commissioning and qualification activities, including FAT/SAT and IQ/OQ documentation.
Provide process engineering input during design reviews, equipment selection, and installation phases.
Maintain and enhance manufacturing and packaging quality systems to ensure compliance with FDA, EMA, and related regulations.
Develop and improve SOPs, work instructions, and quality documentation related to manufacturing and packaging processes with a focus on lifecycle management.
Lead and implement change management strategies for manufacturing and packaging, supporting product lifecycle changes and minimizing operational impact.
Manage and review equipment change requests to ensure timely, accurate, and compliant updates.
Collaborate with regulatory, quality, and manufacturing teams to evaluate and execute changes, supporting a first‑time‑right approach.
Plan, execute, and oversee manufacturing and packaging projects from concept through implementation, ensuring alignment with product launch timelines and regulatory requirements.
Develop project scopes, timelines, and resource plans to ensure seamless coordination with cross‑functional teams.
Identify project risks and implement risk mitigation strategies including process improvements, supply chain redundancy, and regulatory compliance.
Analyze existing manufacturing and packaging workflows, identify opportunities for process improvements, and implement best practices to increase efficiency and reduce risk.
Drive continuous improvement initiatives to streamline manufacturing and packaging processes, enhancing compliance, productivity, and cost‑effectiveness.
Provide technical expertise and troubleshooting support for manufacturing and packaging issues, including root cause analysis and corrective action planning.
Support manufacturing operations including issue trending and improvement projects.
Ensure that all manufacturing and packaging specifications meet regulatory/process standards.
Serve as a key liaison between quality assurance, manufacturing, regulatory affairs, and supply chain to align manufacturing strategies with overall business objectives.
Support product launches, updates, and regulatory requirements by coordinating with cross‑functional teams to achieve timely and compliant product releases.
Act as a product manager for manufacturing and packaging equipment, ensuring that product development aligns with market needs and regulatory standards.
Monitor market trends and competitor products to identify opportunities for innovation and improvement in manufacturing and packaging equipment.
Develop and maintain product roadmaps, ensuring alignment with business goals and customer needs.
Collaborate with marketing and sales teams to develop product positioning and messaging that differentiates our products in the market.
Qualifications And Requirements
Education: Bachelor’s degree in Engineering (Mechanical, Chemical, or Process), Regulatory Affairs, or a related field.
Minimum of 7–11 years of experience in pharmaceutical manufacturing and packaging, with specific expertise in process engineering and equipment management.
Strong background in equipment commissioning, instrumentation, and process validation.
Deep understanding of cGMP, FDA, EMA, and USP guidelines relevant to manufacturing and packaging. Proficiency with quality systems including change control and quality events.
Demonstrated success in managing multiple projects in parallel.
Knowledge, Skills, and Abilities
Excellent communication skills with the ability to work effectively across departments and influence stakeholders.
Strong project management skills, with the ability to manage multiple projects simultaneously.
Strong leadership and team management abilities.
Detail‑oriented with strong analytical and problem‑solving capabilities.
Ability to work in a fast‑paced, dynamic environment.
Essential Functions
Regular use of computer keyboard and mouse; reaching with hands and arms; talking and listening.
Frequent walking and sitting; occasional lifting of objects up to 25 pounds.
Occasional standing, stooping, or kneeling.
Specific vision abilities including close vision and the ability to adjust focus.
Moderate noise level, indoor temperate environment, and bright lighting typical of an office setting.
Total Rewards Program We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company‑paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more suitable, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.
Applicants must have current work authorization when accepting a position at Syner‑G. Currently, Syner‑G is unable to sponsor or take over sponsorship of an employment Visa at this time.
Legal Statement Syner‑G BioPharma Group is proud to be an Equal Employment Opportunity and affirmative action employer. All employment decisions, including recruitment, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to race, color, creed, religion, sex, pregnancy, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected status.
Syner‑G BioPharma is an E‑Verify employer.
#J-18808-Ljbffr