Technical Manufacturing Services Specialist

Highly Competitive Salary
  1. Permanent
  2. Manufacturing, Autoclave, Operations Management
  3. United States
Cambridge, USA
Posting date: 05 Mar 2021
EN.AT.36133

Proclinical is currently recruiting for a Technical Manufacturing Services Specialist, with a background in small molecule manufacturing, for an exciting and rapidly growing biopharmaceutical company based in Cambridge, MA. As the Technical Manufacturing Services Specialist, you will be a key contributor towards maintaining compliance at the company's manufacturing site whilst also facilitating improvements to their documentation, procedures, and wider processes, ensuring best practices are being implemented.

Job Responsibilities:

  • Lead root cause investigations, develop CAPAs and other relevant documents to resolve deviations.
  • Author and submit revisions to documents to support GMP Operations. These include: SOPs, Work Instructions and MBRs
  • Support the development and validation of data reporting as it relates to continuous manufacturing
  • Troubleshoot analytical instruments and methods.
  • Apply GMP concepts to ensure consistent and compliant practices across manufacturing operations.

Skills and Requirements:

  • Bachelor's Degree in a pharmaceutical science or engineering discipline
  • Proven experience in a GMP manufacturing facility
  • Thorough understanding of cGMP concepts and practices
  • Previous experience in Small Molecule and Solid Oral Dosage manufacturing
  • Knowledge of troubleshooting lab equipment and analytical methods
  • In-depth knowledge of learning theories and instructional design models
  • Lesson and curriculum planning skills
  • Basic HTML and Flash programming knowledge
  • Visual design skills (Dreamweaver, Photoshop, Illustrator)
  • Ability to write effective copy, instructional text, audio and video scripts

If you are having difficulty in applying or if you have any questions, please contact Alex Tooulas at (+1) 917-284-9670 or a.tooulas@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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