Senior Manager, Senior Process Validation Engineer, Cell Therapy

Bristol Myers Squibb • Devens, MA

1d

About The Position

The Senior Manager, Senior Process Validation Engineer, provides process validation support to the Devens Cell Therapy Facility (CTF). The Senior Manager leads and participates in facility and process validation activities, including process tech transfers and lifecycle management changes. Responsible for leading Process Validation activities including, but not limited to Product Lifecycle Management changes, Process Performance Qualifications (PPQ), microbial hold studies, and comparability studies. Technical subject matter expert for facility start up, technology transfer, and process validation. Performs data analysis, including the use of statistics, and prepares written protocols/reports/summaries supporting validation studies. Supports equipment and facility commissioning, qualification and validation. Leads/Owns complex site Change Controls Participates in/Leads facility and process risk assessments and authors qualification/ validation documents (e.g. procedures, protocols and reports) in accordance with internal and external regulatory expectations. Supports investigations and global change controls as required. Ensures safe and compliant cGMP operations, maintains permanent inspection readiness, and actively supports regulatory inspections as a Subject Matter Expert. Identifies, prioritizes and drives continuous improvements that reduce safety risks, operational costs, lead times, scrap, and discrepancy rates across all aspects of production. Promotes problem identification and the creation of meaningful solutions through a culture of proactive problem prevention. Serves as a MS&T representative on cross-functional and multi-site teams. Builds and maintains effective collaborative relationships across the site and network, influencing site and network product/process life cycle programs This position reports to the Associate Director of Manufacturing Science and Technology Validation.

Requirements

• Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
• Proficient in facility/clean room design, process, equipment, automation, and process validation.
• Proficient in assessing and implementing product lifecycle changes and leading cross-functional teams
• Proficient in authoring regulatory submissions
• Experience with internal and health authority audits, particularly pre-licensure inspections (PLIs)
• Excellent verbal/written communication skills and ability to influence at all levels
• Ability to think strategically and to translate strategy into actions
• A Minimum of a Bachelor's degree in science, engineering, biochemistry, or related discipline is required.
• Minimum of 8 years of direct experience in biopharmaceutical operations is required. This experience must include hands-on work in cGMP manufacturing environments. Related or equivalent experience in other industries does not satisfy this requirement.

Responsibilities

• Leads and participates in facility and process validation activities, including process tech transfers and lifecycle management changes.
• Responsible for leading Process Validation activities including, but not limited to Product Lifecycle Management changes, Process Performance Qualifications (PPQ), microbial hold studies, and comparability studies.
• Technical subject matter expert for facility start up, technology transfer, and process validation.
• Performs data analysis, including the use of statistics, and prepares written protocols/reports/summaries supporting validation studies.
• Supports equipment and facility commissioning, qualification and validation.
• Leads/Owns complex site Change Controls
• Participates in/Leads facility and process risk assessments and authors qualification/ validation documents (e.g. procedures, protocols and reports) in accordance with internal and external regulatory expectations.
• Supports investigations and global change controls as required.
• Ensures safe and compliant cGMP operations, maintains permanent inspection readiness, and actively supports regulatory inspections as a Subject Matter Expert.
• Identifies, prioritizes and drives continuous improvements that reduce safety risks, operational costs, lead times, scrap, and discrepancy rates across all aspects of production.
• Promotes problem identification and the creation of meaningful solutions through a culture of proactive problem prevention.
• Serves as a MS&T representative on cross-functional and multi-site teams.
• Builds and maintains effective collaborative relationships across the site and network, influencing site and network product/process life cycle programs

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior