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.
The Validation Engineer authors, reviews, and executes qualification and validation documents with processes including process equipment, controlled temperature units, critical utilities, facility, and sterilization of equipment. The position requires experience with GDP, authoring and reviewing documents, and use of Industry and Regulatory Guidelines.
- Author, review, and execute qualification and validation documents and manage validation activities of cross-functional teams including engineering, operations, and quality
- Temperature mapping using Temperature Mapping Systems
- Perform qualification work on critical utilities systems, new equipment, processes and control systems
- Perform qualification work on sterilization equipment
- Perform Cleaning Verification and Validation
- Perform qualification work on controlled temperature-controlled units
- Write final reports summarizing qualification work
- Perform validation assessments on corrective work orders
- Participates in the change control process and provides assessments from a advising on validation perspective issues, as appropriate
- Hands on role in the development and execution of DQ, IQ, OQ and PQ activities
- Provide technical assistance on current US FDA and EU validation requirements for solid Bulk Drug Substance manufacturing, aseptic processing, cleaning, and sterilization of equipment.
- Participate in requalification of equipment, facility and utilities. Ensure that the validation status of equipment and systems are within cGMP compliance within cGMP at all times.
- Maintain validation documentation through the approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans.
- Bachelor’s Degree in Engineering or closely related scientific field
- 2-5 years of experience with the following:
- Preferable: Post-graduate studies as appropriate to augment primary degree
- Experience with Quality management (CAPAs, Deviations, Change Control, Quality Risk Management)
- Computerized System Validation
- Data Integrity Compliance
- Must have strong technical writing skills
- Must have strong oral and written communication skills
- Must have strong computer skills including experience with the following:
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.
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