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Reference # : 17-00724 Title : Process Engineer II
Location : Cambridge, MA
Position Type : Contract
Experience Level : Start Date : 07/24/2017  
Position: Process Engineer II

We are seeking a talented and passionate individual who thrives in a dynamic, fast-paced, team oriented and collaborative environment to be part of our success in the CMC-Operations group. This hire will drive the maintenance, calibration and validation of all relevant equipment used at in the production for our Client, testing and optimization of Client protein therapeutics. You will also be the key contact for all equipment related inquiries, both internal and external. The position requires a self-driven, personable individual with intellectual flexibility, great communication skills and problem solving mentality to successfully complete multiple tasks. The dynamic CMC-Operations group works collaboratively and is looking for a team member with drive, passion, and the ability to work hard while having fun.
What will you be doing/Responsibilities:
  • Coordination of all validation, calibration and documentation of all equipment used in the testing, manufacturing or optimization of drug substance material
  • Will be the primary contact for all external technicians entering the facility to perform calibration, validation or repairs to all cGMP equipment
  • Responsible for the reviewing, executing and approval of all certificates of calibration, as found report, qualification protocols and validation reports
  • Responsible for communicating and initiating appropriate GMP documentation in the event item(s) do not meet the specified operating criteria in the form of deviations, out of tolerance reports, risk assessments, change controls and investigations where applicable
  • Assist with remediation, review or revalidation of existing, new or repaired equipment
  • Experience in the operation and use of building managements systems and HVAC operation and controls
  • Provide input and guidance to all associated standard operating procedures (SOP's), current validation protocols all equipment related risk assessments and associated GMP documentation
  • Maintain, update and revise, as needed, the electronic equipment data base. Currently managed by Master Control
  • Maintain and manage the current Engineering Document Control (EDC) room and all current and new information associated with our Client's equipment
  • Develop long range plan to address obsolescence of equipment and replacement strategy, including budgeting, procurement, delivery and installation
What are we looking for?
The position requires a B.S. in scientific/technical field (Chemistry, biology or Engineering) with 3-5 years of experience. The appropriate candidate must have thorough knowledge and understanding of cGMP's, FDA and pharmaceutical industry guidelines. Candidates should also have experience with temperature mapping procedures and equipment using validation protocols.
How will you grow with us?
Our mission is to build a portfolio of innovative medicines that transform patients' lives by leveraging our research and expertise in the TGF-beta superfamily. This opportunity will allow you to grow in your career by owning and driving challenging and hands-on projects with mentorship from the CMC-Operations group. Develop in your career while helping us achieve our mission and join our team!