Lead Validation Engineer II

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 & 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 & maximum allowable
carry-over limit calculations with rationale; process &
cleaning validation in commercial pharmaceutical cGMP MoH
regulated industry; & use of deviation, change management,
& electronic documentation management systems. Exp must
include 1 yr each of the following: JMP or other statistical
software; statistical analysis; Valgenesis, Veeva, & Trackwise;
process & cleaning of microsphere equipment & 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; & cleaning validation sample
collection. Exp may be gained concurrently. To apply, please
send resume via email to Shawna.Weidman@alkermes.com
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