Senior Validation Engineer
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
Position in Canton, MA. Multiple position openings. Author, review, execute validation documents. Perform commissioning and qualification activities, system impact and validation impact assessments, review system specification documents and create traceability matrixes. Develop, execute and review commissioning, qualification, and validation test plans & protocols. Perform validation activities according to timeline commitments, site and team metrics including developing an execution plan with timeline, deliverables, and accountabilities. Provide validation review and input for CAPAs and Deviations.
Requires a Masters degree or foreign equivalent in Pharmaceutical Sciences, Chemistry, Microbiology, or related and two years of experience as a Validation Engineer, or related; or a Bachelors degree or foreign equivalent in Pharmaceutical Sciences, Chemistry, Microbiology, or related and five years of experience as a Validation Engineer, or related. Must possess experience with Kaye Validator equipment, CIP, SIP, Autoclaves, Controlled Temperature units, Critical Utilities, Facilities, Equipment systems, Computer or Controls Systems used in a GMP environment; strong knowledge of commissioning, qualification validation, ISPE, EU, CFR 210, 211, Part 11, and BPE governmental regulations.
Apply to Emergent Biodefense Operations Lansing LLC with letter and resume at https://Career8.Successfactors.Com/Career?Company=Ebsi
4842-6302-0017, v. 1
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.