Employment Type : Full-Time
Senior Process Validation Engineer
Responsibilities
We are currently looking for a candidate to support a client in Plainville, MA with the following requirements:
• Support Investigations and CAPA execution
• Trend process performance to assess batch performance
• Review and approve batch records for manjufacturing
• Assess training proficiency of, and provide training to shift personnel
• Liaison between process scale-up and cGMP with direct influence over process decisions
• Support process and equipment troubleshooting on the shift, as needed.
• Identify and implement standardized work and process improvements
• Proficient and knowledgeable in relevant process operations.
• Lead on-the-floor manufacturing execution.
• proficient in cell culture operations such as Biosafety Cabinet Operation, Cell Banking, Bioreactor Operations, Aseptic Technique and Centrifuge Harvest Operations.
• Proficient in the operation of all area specific production equipment such as column chromatography operations, tangential flow filtration, formulations and column packing
• Proficient in basic analytical testing (e.g., protein concentration, osmolarity, pH and etc.)
Requirements
• You’ve earned your BS in chemical, biomedical, or biochemical engineering, biological sciences, or related field/experience.
• You’ve gained 5 years relevant industry experience working in a cGMP environment., with 4 years minimum in biotechnology or pharmaceutical experience required.
Rate $52.00/hr.