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Sr. Engineer MS&T

2 months ago

Norwood, United States Randstad Life Sciences US Full time

A major Pharmaceutical company whose mission is to deliver the greatest possible impact to people through innovative medicines. Join us to make a world of Change in Health Care

Seeking a Technical Leader for Consumables and Raw Materials to enhance our MS&T capabilities,

What We Offer:

  • A collaborative and innovative work environment.
  • The chance to work with a dedicated team focused on advancing medical technology.


The Role: As a Technical Leader, you'll manage the lifecycle of consumables and raw materials, including new material introduction, consumable design, troubleshooting, change assessments, and support for scale-up and tech transfer activities. strong GMP quality systems, processing equipment, unit operations, and regulatory guideline knowledge are essential. Effective team leadership and cross-functional coordination are key.

Key Responsibilities:

  • support and improve business processes for introduction of new consumables and/or raw materials.
  • Lead resolution of internal and supplier deviations, and identification of corrective actions
  • Lead impact assessment of supplier change notifications, with awareness of technical, quality, and regulatory implications.
  • Design and optimize single use consumables, assuring functional requirements are well defined and supplier selection is aligned with sourcing strategy.
  • Provide technical expertise and guidance to establish robust unit operations.
  • Support supplier relationships, collaborations, and troubleshooting as a technical representative.
  • Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
  • Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
  • Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
  • Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
  • Additional duties as may be assigned from time to time


Requirements:


  • BS/MS in Chemical Engineering, Material Science, or related discipline.
  • Minimum of 5 years in process development, manufacturing, or engineering. (8-12 years preferred)
  • Understanding of GxP and GMP regulations.