Senior Cold Chain Validation Engineer - Biologics
FPCNational - Massachusetts

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Growing Biopharmaceutical leader seeks Sr Validation Engineer and Cold Chain expert to lead in the following:

Initial Top Challenges:
1) Lead development of Cold Chain qualifications, process, validation, equipment validation and packaging and labeling qualifications
2) Define strategies for external validation efforts, including development of master plans/ project plans etc
3) Gain consensus on protocol content, protocol execution, and resolution to failures to meet protocol requirements
4) Act as a validation subject matter expert for resolution of deviations, CAPA’s, change controls and other quality systems.
5) Continuous improvement activities related to validation, quality, and compliance.

Salary : Base will be dependent on your expertise and should range from the 80’s to 100k. Bonus, benefits and relocation also available
Location : Massachusetts
Contact : Apply below and/or at and/or contact Ira Mann at

1) 4+ years of recent validation experience in pharmaceutical or biopharmaceutical
2) BS Degree in Engineering (Chemical or Biochemical preferred)
3) Cold Chain experience (qualification and/or packaging and labeling qualification for cold chain product)

Key Words: cold chain, shipping validation, packaging and labeling qualification, process validation, drug product