Bristol Myers Squibb
Senior Specialist, Associate Aseptic Process Validation Engineer
Devens - MA - US · Senior · Part-time
Sponsorship not specified$88k-$106kDetected 11 hours ago
AccessibilityExcelClinical TrialsGMPCommunicationCollaboration
About the role
- Additional incentive cash and stock opportunities (based on eligibility) may be available.
- Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment.
Responsibilities
- Authors qualification/validation documents (e.g. procedures, protocols and summary reports) and ensures Manufacturing readiness for APS execution.
- Participates in/Leads aseptic risk assessments and authors associated summary reports.
- Ensures safe and compliant cGMP operations, maintains permanent inspection readiness, and actively supports regulatory inspections as a Subject Matter Expert.
- Builds and maintains effective collaborative relationships across the site and network, influencing site and network product/process life cycle programs
- Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible.
Requirements
- Knowledge of science generally attained through studies resulting in a Bachelor's degree in science, engineering, biochemistry or related discipline, or its equivalent is required
- A minimum of 2 years' experience in biopharmaceutical operations, or its equivalent is required
- The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience.
- Leads/Owns site Change Controls as required
- Supports investigations and global change controls as required
- BMS has an occupancy structure that determines where an employee is required to conduct their work.
Skills
- Experience in cGMP's and multi-national biopharmaceutical/cell therapy regulations
- Experience in aseptic processing/validation and facility/clean room design.
- Experience with internal and health authority audits
- Excellent verbal/written communication skills
Compensation
- 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.
Benefits
- Medical, pharmacy, dental, and vision care.
- Work-life benefits include:
- With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary.
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This listing is sourced directly from Bristol Myers Squibb's careers page and normalized into a canonical job model.