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Lead Validation Engineer Il Lead Validation Engineer II at Alkermes, Inc. (Wilmington, OH). Lead efforts to prove control of the critical aspects of Alkermes operations with a focus on process &amp; cleaning validation. Reqts: Bachelor’s degree in Pharmaceutical Science, Biomedical Science, Biomedical Engineering or a related field + 5 yrs of validation exp in the pharmaceutical industry. Exp must include 5 yrs each of the following: defining validated cleaning campaign lengths &amp; maximum allowable carry-over limit calculations with rationale; process &amp; cleaning validation in commercial pharmaceutical cGMP MoH regulated industry; &amp; use of deviation, change management, &amp; electronic documentation management systems. Exp must include 1 yr each of the following: JMP or other statistical software; statistical analysis; Valgenesis, Veeva, &amp; Trackwise; process &amp; cleaning of microsphere equipment &amp; long-acting injectable recrystallizations / suspensions; qualification of parts washer loads; OSD cleaning sampling; wearing of gowning PPE including respirator used in manufacturing areas utilizing potent compounds; &amp; cleaning validation sample collection. Exp may be gained concurrently. To apply, please send resume via email to <a href="mailto:Shawna.Weidman@alkermes.com" target="_blank">Shawna.Weidman@alkermes.com</a> or mail to Alkermes, Inc., c/o Shawna Weidman, 900 Winter Street, Waltham, MA 02451-1420. Please reference job title (Lead Validation Engineer Il). AIMXNSP11651

1 Quality Control Job