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Senior Engineer

3 months ago

Norwood, United States Randstad Full time

Our client, located in Norwood, Massachusetts, is seeking a Senior Engineer I to join their team. This is a temporary 6-8 month position to start as soon as possible.


In this role, you will represent an expansion of current MS&T capabilities, providing opportunity for leadership, growth, and visibility. The individual is expected to provide technical leadership for consumables and/or raw materials. This may comprise aspects across the material life cycle, including introduction of new materials, design of consumables, investigations and troubleshooting, assessment of change notifications, and supporting scale up and tech transfer activities. The role requires a strong background in GMP quality systems, processing equipment and unit operations, and regulatory guidelines for pharmaceutical manufacturing. Strong communication skills are required for effective team leadership and cross-functional coordination.


Job Duties:

  • 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


Basic Qualifications:

  • BS / MS in chemical engineering, material science, or related technical discipline
  • Minimum of 5 years of industry experience in process development, manufacturing, engineering, or similar technical role. 8-12 years preferred.
  • Demonstrated aptitude or ability to learn to gain a strong understanding of GxP and GMP regulations.
  • This position is site-based, requiring you to be at the client’s site full-time. This position is not eligible for remote work.


Preferred Qualifications:

  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.