4630 Process Validation Associate
Responsible for supporting process validation (PV) activities.
Deliverables include management of PV document schedule, facilitating document reviews, assisting with PV sampling activities (lab).
Will also assist with large and small-scale PV and tech transfer studies, as needed.
Assist with PV document reviews for Process Engineering:
Manage document review workflows; ensure correct content and formatting.
Facilitate communications with authors and document approvers to ensure adherence to PV document schedule.
Optimize document review process within the eVAL validation document system.
Coordinate with authors to develop PV sampling plan.
Provide PV schedule reports/updates to cross-functional teams.
Take meeting minutes.
Assist with large and small-scale studies to support process validation and tech transfer:
Perform required operations at pilot and small scale.
May include: cell culture, chromatography, filtration, analytical, or mixing studies.
Experiment data recording, collection, and analysis. He/she should be able to present information timely, clearly, and confidently.
Assist technical teams in support of site investigations and commercial make-assess-release.
Participate in OLP (Oceanside Lab and Pilot Plant) weekly 5S activities.
All employees with jobs that require access to the Warehouse must be able to pass the
Transportation Security Administration (TSA) Security Threat Assessment (STA).
Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.
Fosters a positive safety culture in which no one gets hurt.
May act as Subject Matter Expert for the purposes of training OLP personnel.
Embraces open communication, teamwork and transparency by aligning efforts and knowledge sharing.
Bachelor’s or Master’s degree in Engineering or Life Sciences.
4-6 years experience in relevant field.
2-4 years with Master.
Knowledge, Skills, and Abilities
Experience with Microsoft SharePoint
Proven management, communication, interpersonal, organizational and project management skills.
Demonstrated ability to work as part of a multi-disciplinary team.
Ability to interact within and across work groups and with outside collaborators and vendors on technical matters.
Demonstrated technical proficiency
Practical and theoretical expertise in biopharmaceutical manufacturing processes engineering and applied technologies.
Strong oral and written communication skills.
Work Environment/Physical Demands/Safety Considerations
Work in office and, to a lesser extent, laboratory environment.
May be on feet for 4 to 5 hours a day.
Lifting up to 25 lbs may be required.
May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment.
May work with hazardous materials and chemicals.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.