Bristol Myers Squibb
Senior Manager Validation Engineering
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Senior Manager Validation Engineering – Bristol Myers Squibb.
Devens, MA
Working with Us Challenging. Meaningful. Life‑changing. Bristol Myers Squibb transforms the lives of patients and the careers of the people who do it. From optimizing a production line to breakthroughs in cell therapy, we innovate every day and offer unparalleled growth opportunities alongside high‑achieving teams.
Position Senior Manager Validation Engineering
Location Devens, MA
Key Responsibilities
Lead functions within the Validation Engineering group responsible for the qualification lifecycle of facility, utility and processing equipment systems.
Lead functions responsible for installation, operational and performance qualification (I/O/PQ) of systems arising from projects and change controls.
Lead the site Periodic Assessment and Requalification program by establishing procedures aligned with BMS directives and industry guidance, ensuring execution to predefined schedule.
Establish validation project plans, manage execution of validation projects whose scope, regulatory visibility, schedule, and complexity require coordination with customers, collaborators, and quality.
Oversee validation execution work arising from change controls, capital projects, shutdown/change‑over activity, and ongoing revalidation programs.
Deliver validation projects under strict deadlines to ensure customer success and bulk drug supply, establishing plans, protocols, test scripts, risk assessments, and summary reports.
Manage multiple projects while serving as a point of contact for validation execution projects.
Act as a validation subject‑matter expert, presenting validation philosophies and strategies to Board of Health (BOH) inspectors and auditors.
Collaborate with Engineering, Digital Plant, Manufacturing and Quality.
Effectively manage assigned resources to prioritize schedules, maximize productivity, reduce costs and increase efficiencies.
Ensure alignment with BMS directives and industry guidelines on validation.
Develop and lead a high‑performance team, managing recruitment, development, coaching, mentoring, and recognition.
Establish and communicate high performance standards, define clear accountability and lead continuous‑improvement strategies to reduce operational variances and cycle time.
Qualifications & Experience
BS in engineering or related discipline, or equivalent industry experience.
Minimum of 6 years relevant experience with process equipment, automation, and laboratory instrumentation in a biologics manufacturing facility.
Direct experience with equipment, facility, sterilization qualification, critical utilities validation, and temperature‑mapping concepts.
Previous managerial experience demonstrating selection, motivation, retention, personnel issue management, and financial resource planning.
Experience presenting validation philosophies, strategies and results to BOH inspectors, external auditors, corporate and internal auditors.
Familiarity with distributed control systems, automation (GAMP) validation concepts for cross‑functional validation efforts.
Working understanding of lean principles preferred. Excellent project management, communication, and technical writing skills required.
Professionalism and technical competency to represent the department before customers, regulatory agencies, and management.
Understanding of engineering documentation such as P & ID, process flow diagrams, standard operating procedures.
Knowledge of regulatory validation requirements including FDA, EMA, ICH Q7, Q8, Q9 for biologics manufacturing.
Proven ability to lead multi‑level, cross‑functional teams in a matrix environment toward site and departmental objectives.
Compensation Overview Devens, MA – US $139,460 – $168,992 (annual). Additional incentive cash and stock options may be available based on eligibility.
Benefits Competitive medical, pharmacy, dental, vision, and well‑being programs; 401(k) with company match; paid vacation and holidays; work‑life flex programs; and more.
Equal Employment Opportunity Bristol Myers Squibb is an equal‑employment opportunity employer and encourages applicants of all backgrounds. Learn more at https://careers.bms.com/eeo-accessibility.
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Devens, MA
Working with Us Challenging. Meaningful. Life‑changing. Bristol Myers Squibb transforms the lives of patients and the careers of the people who do it. From optimizing a production line to breakthroughs in cell therapy, we innovate every day and offer unparalleled growth opportunities alongside high‑achieving teams.
Position Senior Manager Validation Engineering
Location Devens, MA
Key Responsibilities
Lead functions within the Validation Engineering group responsible for the qualification lifecycle of facility, utility and processing equipment systems.
Lead functions responsible for installation, operational and performance qualification (I/O/PQ) of systems arising from projects and change controls.
Lead the site Periodic Assessment and Requalification program by establishing procedures aligned with BMS directives and industry guidance, ensuring execution to predefined schedule.
Establish validation project plans, manage execution of validation projects whose scope, regulatory visibility, schedule, and complexity require coordination with customers, collaborators, and quality.
Oversee validation execution work arising from change controls, capital projects, shutdown/change‑over activity, and ongoing revalidation programs.
Deliver validation projects under strict deadlines to ensure customer success and bulk drug supply, establishing plans, protocols, test scripts, risk assessments, and summary reports.
Manage multiple projects while serving as a point of contact for validation execution projects.
Act as a validation subject‑matter expert, presenting validation philosophies and strategies to Board of Health (BOH) inspectors and auditors.
Collaborate with Engineering, Digital Plant, Manufacturing and Quality.
Effectively manage assigned resources to prioritize schedules, maximize productivity, reduce costs and increase efficiencies.
Ensure alignment with BMS directives and industry guidelines on validation.
Develop and lead a high‑performance team, managing recruitment, development, coaching, mentoring, and recognition.
Establish and communicate high performance standards, define clear accountability and lead continuous‑improvement strategies to reduce operational variances and cycle time.
Qualifications & Experience
BS in engineering or related discipline, or equivalent industry experience.
Minimum of 6 years relevant experience with process equipment, automation, and laboratory instrumentation in a biologics manufacturing facility.
Direct experience with equipment, facility, sterilization qualification, critical utilities validation, and temperature‑mapping concepts.
Previous managerial experience demonstrating selection, motivation, retention, personnel issue management, and financial resource planning.
Experience presenting validation philosophies, strategies and results to BOH inspectors, external auditors, corporate and internal auditors.
Familiarity with distributed control systems, automation (GAMP) validation concepts for cross‑functional validation efforts.
Working understanding of lean principles preferred. Excellent project management, communication, and technical writing skills required.
Professionalism and technical competency to represent the department before customers, regulatory agencies, and management.
Understanding of engineering documentation such as P & ID, process flow diagrams, standard operating procedures.
Knowledge of regulatory validation requirements including FDA, EMA, ICH Q7, Q8, Q9 for biologics manufacturing.
Proven ability to lead multi‑level, cross‑functional teams in a matrix environment toward site and departmental objectives.
Compensation Overview Devens, MA – US $139,460 – $168,992 (annual). Additional incentive cash and stock options may be available based on eligibility.
Benefits Competitive medical, pharmacy, dental, vision, and well‑being programs; 401(k) with company match; paid vacation and holidays; work‑life flex programs; and more.
Equal Employment Opportunity Bristol Myers Squibb is an equal‑employment opportunity employer and encourages applicants of all backgrounds. Learn more at https://careers.bms.com/eeo-accessibility.
#J-18808-Ljbffr