Senior Process Validation Engineer

  • Contractor
  • Full-Time
  • Plainville, MA
  • Splintpharma
  • Prefferd visa: OPT, CPT, F1, H4, Have H1 Visa, Need H1 Visa, EAD
  • Posted 1 year ago – Accepting applications
Job Detail
  • Offerd Salary $ 42 - $ 52
  • Required Position 2-4 hires
  • Experience 0-4 Years Required
Job Description

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.

Job Requirement

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.

Required skills