Validation Engineer II/III - BPD
The Validation Engineer II/III will write, execute, and review Validation Protocols and Summary Reports for Equipment Installation/Operational/Performance Qualifications (IQ/OQ/PQ) for all functions supporting the Gaithersburg Pilot Facility including Manufacturing, Analytical Sciences, Quality Control, Facilities, and Device functions. Examples of equipment include analytical systems, bioreactors, chromatography systems, controlled temperature units, autoclaves and critical utilities as well as Cleaning Verification Studies, Sterilization Validations, Temperature Mapping Studies and other miscellaneous validation activities.
- Writes, executes, and reviews Validation Protocols and Summary Reports for Equipment Installation/Operational/Performance Qualifications (IQ/OQ/PQ) used in biomanufacturing within a multi-product facility. Examples of equipment includes analytical systems, bioreactors, chromatography systems, controlled temperature units, autoclaves and critical utilities as well as Cleaning Verification Studies, Sterilization Validations, Temperature Mapping Studies and other miscellaneous validation activities.
- Supports review of the facility Validation Master Plan (VMP).
- Support the Computerized System Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidance's on electronic data integrity.
- Authors SOPs for all types of manufacturing equipment and identifies appropriate training requirements are implemented as necessary.
- Ensures validation equipment/lab is kept in good working order.
- Participates and supports manufacturing readiness and tech transfer activities.
- May author batch records, investigations, change controls, specifications and other types of technical reports.
- Identifies gaps and anticipates/mitigates potential areas of risk, performing risk assessments as appropriate.
- Support AstraZeneca’s Internal Audit Program as needed.
Education Requirements & Experience:
Engineer II: Bachelors Degree in Engineering or Science related field. Minimum of 2+ years of validation, cGMP biomanufacturing, or process engineering experience.
Engineer III: Bachelors Degree in Engineering or Science related field. Minimum of 3+ years of validation experience or combination of validation, cGMP biomanufacturing or process engineering experience.
Experience in FMEA, QRM and Six Sigma preferred.
Demonstrated technical writing skills.
Possesses excellent organization and interpersonal skills.
Ability to build effective teams and foster collaborative relationships.
Demonstrates strong presentation and facilitation skills.
Highly motivated self-starter with commitment to meeting established timelines.
Demonstrates creative thinking and a willingness to implement new approaches.
Requires computer expertise in MS Office Suite.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.