Associate/Validation Engineer
Precigen
2 hours ago
On-site
Germantown, MD
$75,000 - $105,000 USD yearly
Operations
Duties and Responsibilities:
- Oversee site Validation Program, coordinating with Metrology, Facilities, User group personnel, and external vendors to ensure proper qualification status of facility systems (e.g., HVAC, backup power, water purification, compressed gas distribution, glass/part washers, autoclaves, refrigerator/freezers), process equipment (e.g., incubators, TFF, FPLC, centrifuges), and analytical equipment (e.g., PCR, environmental monitoring, cell analysis, spectrophotometers). Perform hand-on troubleshooting with OEM/service vendors as needed.
- Conduct Controlled Temperature Mappings for CTU qualifications.
- Provide technical expertise to define qualification requirements for new site systems and improve existing equipment/utilities per the site Validation Master Plan and procedures.
- Participate in project teams requiring validation support.
- Author and review qualification-related SOPs, work instructions (WI), and validation plans.
- Author/review/execute validation protocols and reports (e.g., CTU and autoclave temperature mapping using KAYE validator or similar data logging equipment), engineering studies, and IQ/OQ/PQ for facility, processing, and analytical equipment.
- Collect, compile, and analyze validation data with some/minimal supervision, demonstrating ownership to confirm GMP validated state.
- Support the site Quality Management System (QMS) by authoring/reviewing qualification-related change controls, deviations, and CAPA.
Qualifications/Requirements:
- Bachelor’s degree in Engineering or Life Sciences.
- 2+ years of GMP Qualification experience (level determined by education/experience) with working knowledge of FDA and Eudralex regulations.
- Technical writing experience generating SOPs, protocols/reports, work instructions, and validation plans.
- Strong computer skills: Microsoft Office; Quality Record Management; CMMS; BMS/BAS; EMS; validation data management software; CAD; ability to learn new applications.
- Ability to sit/stand/walk regularly, access mechanical areas, aseptically gown into production suite, and maneuver equipment/supplies up to 40 pounds.
- Oversee site Validation Program, coordinating with Metrology, Facilities, User group personnel, and external vendors to ensure proper qualification status of facility systems (e.g., HVAC, backup power, water purification, compressed gas distribution, glass/part washers, autoclaves, refrigerator/freezers), process equipment (e.g., incubators, TFF, FPLC, centrifuges), and analytical equipment (e.g., PCR, environmental monitoring, cell analysis, spectrophotometers). Perform hand-on troubleshooting with OEM/service vendors as needed.
- Conduct Controlled Temperature Mappings for CTU qualifications.
- Provide technical expertise to define qualification requirements for new site systems and improve existing equipment/utilities per the site Validation Master Plan and procedures.
- Participate in project teams requiring validation support.
- Author and review qualification-related SOPs, work instructions (WI), and validation plans.
- Author/review/execute validation protocols and reports (e.g., CTU and autoclave temperature mapping using KAYE validator or similar data logging equipment), engineering studies, and IQ/OQ/PQ for facility, processing, and analytical equipment.
- Collect, compile, and analyze validation data with some/minimal supervision, demonstrating ownership to confirm GMP validated state.
- Support the site Quality Management System (QMS) by authoring/reviewing qualification-related change controls, deviations, and CAPA.
Qualifications/Requirements:
- Bachelor’s degree in Engineering or Life Sciences.
- 2+ years of GMP Qualification experience (level determined by education/experience) with working knowledge of FDA and Eudralex regulations.
- Technical writing experience generating SOPs, protocols/reports, work instructions, and validation plans.
- Strong computer skills: Microsoft Office; Quality Record Management; CMMS; BMS/BAS; EMS; validation data management software; CAD; ability to learn new applications.
- Ability to sit/stand/walk regularly, access mechanical areas, aseptically gown into production suite, and maneuver equipment/supplies up to 40 pounds.