What are the responsibilities and job description for the Sr Validation Engineer position at Alkermes, Inc.?
Alkermes seeks Sr. Validation Engineer in Wilmington, OH. Apply knowledge in API, DS, DP, Packaging, & Shipping Validation to: develop/execute validation strategies for product launches & technical transfers; review procedures for DEQA-Validation team; support investigations and change management; act as SME for API and contracting service provider audits/qualifications; execute protocols & write summary reports; work with CMOs to ensure documentation meets requirements; implement validation assessment for change controls; develop/maintain API, DS, DP, Shipping, & Packaging Validation Master Plans; identify need for/perform SOP updates. Reqs: Master's in Mechanical Engg, Biomedical Engg, or equiv and 4 yrs exp in Quality Assurance/Technical role in pharmaceutical industry (in alternative, will accept Bach and 5 yrs exp), including 2 yrs in API, DS, DP, Packaging and Shipping Validation, 2 yrs in Pharmaceutical Quality Assurance, 2 yrs implementing/administering quality systems for drug product development/manufacturing; 2 yrs working with US & EU Drug Product GMP requirements/guidelines (including ISO 9001, ISO13485, ICH, ISTA, ASTM and data integrity) (exp can be gained concurrently); occasional domestic & international travel. By resume to careers@alkermes.com.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
