Lead System Designer

Category:
Engineering
Industry:
Healthcare
Type:
Contract
Location:
Westborough, Massachusetts
Job ID:
#159968
Recruiter:
Darakshan Naz

Do you want to work for one of the largest “Healthcare” company in Massachusetts? They are currently looking for an “System Designer” to support their facility in Westborough, MA.  If you’re interested and qualified, we urge you to apply!

Job Purpose:

Coordinate the detailed design and solve any design issues during the design phase and acts as a contract for system design related questions. Participates in developing and updating the Flex Factory project schedule.

Responsibilities:

Support customer meetings by providing system hardware understanding. Develop, explore and recommend manufacturing concepts to fit customer needs/facility requirements.

  • Assure compliance with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
  • Work closely with Customer’s Subject Matter Experts (SMEs) to ensure continuous exchange of critical and technical information needed to execute design activities on time.
  • Complete all planned Quality & Compliance training within defined deadlines.
  • Identify and report any quality or compliance concerns and take immediate corrective action as required.
  • Work closely with Process Design Engineers to ensure that the equipment specification meets customer and process needs, and that equipment layout is optimized for the customer facility.
  • Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDR and NPI program milestones.
  • Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives.

Qualifications/Requirements:

  • BS or MS degree in biochemical / chemical engineering or a related engineering/life Science discipline
  • Minimum of 5 years of relevant bio-process experience.
  • Working knowledge of pharmaceutical/biotech processes, equipment hardware, and single use technology.
  • Thorough knowledge of biologic CMC, cGMP manufacturing requirements.
  • Technical understanding of automation systems used in the bio-pharma (Delta V, PLC, PI, etc.)
  • Experience in working/leading within cross functional teams.
  • Experience with AutoCAD, Visio, MS Project, SuperPro.