biotech

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of

POSITION SUMMARY: We are looking for a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our team on a 12-month contract. The Senior CQV Engineer is responsible for ensuring systems, facilities, and equipment meet design requirements to be put in place for a facility. The in

RQ of Utilities (WFI) Process RQs (SIP, Bulk Sterilization, Autoclave) Cleaning validation Warehouse mapping Filtration skids Mixing tank Washer qualification Trending of Results Data mining LIMS queries Develop, review and/or approve validation lifecycle document and protocols/reports in accordance

Develop and review validation plans, protocols (IQ, OQ, PQ), and reports for computerized systems. Perform risk assessments and impact analysis related to system validation. Ensure compliance with regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaborate with IT, Quality

Lead and execute multiple Change Records (Planned events) for the assigned area for creation of new Batch Records and Standard Operation Procedures for Production Support Change Records Assessment and GMP documentation Review. Responsible for providing support to the assigned manufacturing operation

Learn and perform well-defined procedures within a GMP manufacturing setting Perform equipment monitoring & and basic 6S housekeeping Perform basic laboratory tasks (e.g. sampling, pH / conductivity / osmolality measurements etc.) Perform routine sanitization tasks to maintain facility standards Tra