Sr. Validation Engineer
ImmunoGen, Inc. in Norwood MA is in search of a Sr. Validation Engineer that will develop and execute validation protocols for computerized systems, processing equipment, cleaning procedures, lab equipment, and facility and quality management systems at our clinical manufacturing facility. The key focus of this position will be specifically for computerized systems.
Job Responsibilities include but are not limited to the following:
- Write, review, and approve validation protocols and final reports to include analyzing data, author and review of SOPs
- Complete validation assessments for change control process, revalidation assessments, engineering studies as part of commissioning activities
- Serve as validaition representative on product sub-teams
BS degree in engineering discipline preffered, 8+ years of technical experience in Computer System Validation, Analytical and Manufacturing Equipment Validation. Working knowledge of computer system validation, with strong understanding of GAMP, 21 CFR Part 11, and regulatory requirements, experice in cleaning validation methodology, excellent computer, writing, and communication skills.
Minimal travel required for FAT.
ImmunoGen, Inc. offers an excellent salary and benefits package including 100% paid health and dental insurance, 401(k) and tuition assistance. Please send a detailed resume to: Human Resources Department, ImmunoGen, Inc., 830 Winter Street, Waltham, MA 02451: E-mail: firstname.lastname@example.org. Please reference the ad source/job code in your response.
We are an Equal Opportunity Employer