BioSpace
Associate Director – TS/MS Validation
BioSpace, Pleasant Prairie, Wisconsin, United States, 53158
Overview
Lilly is seeking an Associate Director, Validation responsible for staffing, training, and leadership of the Technical Services/Manufacturing Science (TS/MS) validation group. The role focuses on cleaning validation, sterilization validation, filter validation, controlled temperature storage qualification, and the qualification of equipment, facilities, and utilities. The Associate Director may provide input/guidance/oversight to other validation types as needed and will support day-to-day TS/MS validation activities as well as planning for the 3-6 month horizon.
Pay
Base pay range: $118,500.00/yr - $173,800.00/yr
Responsibilities Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
Support Site Leadership to build a diverse and capable TS/MS organization, with focus on cleaning validation, sterilization validation, filter validation, controlled temperature storage qualification, and the qualification of equipment, facilities, and utilities.
Provide technical guidance to the TS/MS group.
Participate in the development and implementation of strategies related to Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
Support site inspection readiness and execution; interact with Regulatory Agencies during site inspections.
Manage external contracts/resources and project management resources, as needed.
Manage the development and maintenance of validation program documents including SOPs and Master Plans.
Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation master plans, protocols and summary reports, etc.
Support and/or lead TS/MS technical projects to ensure successful start-up, improved process control, yield, product quality and/or productivity.
Work within or lead cross-functional teams to implement TS/MS validation objectives and deliver on business and quality objectives.
Network and collaborate with global and other parenteral sites to share best practices and participate in strategic planning.
Maintain a safe working environment through compliance with safety rules and active participation in safety activities.
Basic Qualifications BS, MS, or Doctorate in Mechanical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or related scientific discipline.
Minimum 1 year of management or leadership experience, including leading or working with cross-functional groups.
Minimum 5 years of regulated industry experience.
Previous experience with aseptic manufacturing.
Additional Skills/Preferences Strong technical aptitude and ability to train and mentor others.
Excellent interpersonal, written, and oral communication skills for effective communication at all levels.
Solid understanding of basic regulatory requirements (FDA, EMEA, OSHA).
Experience supporting cGMP manufacturing (operations, technical services/MSAT, QA, etc.).
Start-up experience in facilities or areas.
Equipment qualification and process validation experience.
Experience with highly automated equipment.
Experience with deviation and change management systems (e.g., MasterControl).
Additional Information Role is Monday through Friday based. Must be flexible to accommodate production schedules, shutdowns, and may require occasional extended hours or off-hour work.
This job description is intended to provide a general overview of the job requirements at the time it was prepared. Job requirements may change over time and may include additional responsibilities. For GMP purposes, update the description for significant changes. Consult with your supervisor regarding actual responsibilities.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and provides equal opportunities. If accommodation is needed to submit a resume, please complete the accommodation request form. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Actual compensation will depend on education, experience, skills, and location. The anticipated wage for this position is $118,500 - $173,800. Full-time employees are eligible for a company bonus and a comprehensive benefits program, including 401(k), pension, vacation, medical/dental/vision, life insurance, and wellness programs.
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Lilly is seeking an Associate Director, Validation responsible for staffing, training, and leadership of the Technical Services/Manufacturing Science (TS/MS) validation group. The role focuses on cleaning validation, sterilization validation, filter validation, controlled temperature storage qualification, and the qualification of equipment, facilities, and utilities. The Associate Director may provide input/guidance/oversight to other validation types as needed and will support day-to-day TS/MS validation activities as well as planning for the 3-6 month horizon.
Pay
Base pay range: $118,500.00/yr - $173,800.00/yr
Responsibilities Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
Support Site Leadership to build a diverse and capable TS/MS organization, with focus on cleaning validation, sterilization validation, filter validation, controlled temperature storage qualification, and the qualification of equipment, facilities, and utilities.
Provide technical guidance to the TS/MS group.
Participate in the development and implementation of strategies related to Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
Support site inspection readiness and execution; interact with Regulatory Agencies during site inspections.
Manage external contracts/resources and project management resources, as needed.
Manage the development and maintenance of validation program documents including SOPs and Master Plans.
Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation master plans, protocols and summary reports, etc.
Support and/or lead TS/MS technical projects to ensure successful start-up, improved process control, yield, product quality and/or productivity.
Work within or lead cross-functional teams to implement TS/MS validation objectives and deliver on business and quality objectives.
Network and collaborate with global and other parenteral sites to share best practices and participate in strategic planning.
Maintain a safe working environment through compliance with safety rules and active participation in safety activities.
Basic Qualifications BS, MS, or Doctorate in Mechanical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or related scientific discipline.
Minimum 1 year of management or leadership experience, including leading or working with cross-functional groups.
Minimum 5 years of regulated industry experience.
Previous experience with aseptic manufacturing.
Additional Skills/Preferences Strong technical aptitude and ability to train and mentor others.
Excellent interpersonal, written, and oral communication skills for effective communication at all levels.
Solid understanding of basic regulatory requirements (FDA, EMEA, OSHA).
Experience supporting cGMP manufacturing (operations, technical services/MSAT, QA, etc.).
Start-up experience in facilities or areas.
Equipment qualification and process validation experience.
Experience with highly automated equipment.
Experience with deviation and change management systems (e.g., MasterControl).
Additional Information Role is Monday through Friday based. Must be flexible to accommodate production schedules, shutdowns, and may require occasional extended hours or off-hour work.
This job description is intended to provide a general overview of the job requirements at the time it was prepared. Job requirements may change over time and may include additional responsibilities. For GMP purposes, update the description for significant changes. Consult with your supervisor regarding actual responsibilities.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and provides equal opportunities. If accommodation is needed to submit a resume, please complete the accommodation request form. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Actual compensation will depend on education, experience, skills, and location. The anticipated wage for this position is $118,500 - $173,800. Full-time employees are eligible for a company bonus and a comprehensive benefits program, including 401(k), pension, vacation, medical/dental/vision, life insurance, and wellness programs.
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