Alkermes, Inc.
Lead Validation Engineer Il
Wilmington, OH
Responsibilities: Serve as subject matter expert in & lead
equipment, facility, & utility qualification for clinical & commercial
pharmaceutical manufacturing & laboratory systems. Serve as
technical lead for maintenance of GMP compliance through
monitoring, review, assessment & qualification of activities.
Ensure Validation systems (policies, procedures, reviews, VMPs)
effectively meet current/changing industry demands.
Salary: $135,000 - $150,000/year
Requirements: Bachelor's in Pharmaceutical Science,
Biomedical Science, Biomedical Engg or related field & 8 years
of validation exp in pharmaceutical industry. Exp must include
5 years each of following: performing equipment, facilities, &
utilities qualification/validation in commercial pharmaceutical
cGMP MoH regulated industry; using deviation, change
management, & electronic documentation management
systems; Valgenesis, Veeva, Maximo, or Trackwise; temperature
mapping data logging systems & software, such as Ellab, Val
Probe, Kaye validator AVS or 2010, TMI-Orion, or Temptale; root
cause analysis tools; wearing gowning PPE used in aseptic &
non-aseptic manufacturing areas; & performing risk analysis/
assessment. Exp may be gained concurrently. Send resume &
cover letter to: Alkermes, Inc. Attn: Shawna Weidman, 900 Winter
Street, Waltham MA, 02451 or
(reference Lead Validation Engineer Il).
JobiqoTJN. Keywords: Quality Control / Quality Assurance Engineer, Location: Wilmington, OH - 45177
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: pandfeed
- Position Id: 604222521
- Posted 9 hours ago
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