Lead Validation Engineer II

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

Shawna.Weidman@akermes.com

(reference Lead Validation Engineer Il).