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Manufacturing Operations Specialist Jobs

Company

Vertex Pharmaceuticals
Address , Boston, 02110, Ma
Employment type FULL_TIME
Salary
Expires 2023-07-19
Posted at 11 months ago
Job Description
General Summary:
The Manufacturing Operations Specialist will assist in the day-to-day manufacturing operations at the Vertex Manufacturing Center. Under supervision, the incumbent will be working in the Drug Production facility performing the set-up, operation, disassembly, and cleaning of process equipment to manufacture Vertex's Commercial and Development/Clinical Drug Products. The incumbent will work in collaboration with drug product development teams through all phases of development, process validation and commercialization to understand process requirements and provide feedback on process performance.
Key Duties and Responsibilities:
  • Execute and witness batch record instructions during cGMP operations
  • Interface with cleaning staff, and Facilities/Operations to make sure the facility meets its intended use requirements as well as to schedule routine cleaning and all the necessary calibration and preventive maintenance activities
  • Monitor GMP compliance in all cGMP activities with co-workers and anyone working within the Drug Product facility
  • Interface with all appropriate key stakeholders, such as Quality and EH&S to ensure appropriate procedures are followed to ensure successful operation of the drug product facility
  • Interface with Materials Management and the Release and Stability Laboratory to coordinate the purchase and delivery of necessary materials and the testing of routine cleaning and release samples.
  • Following SOPs, policies and all other relevant work instructions to ensure the successful and compliance operation of the drug product facility
  • Follow strict adherence to cGMP requirements including:
  • Compliance with all on-going training requirements
Knowledge and Skills:
  • Basic understanding of the cGMP framework in the context of both development and commercial pharmaceutical drug product manufacturing environment
  • Experience with manufacturing systems utilizing computerized control systems and HMIs
  • Good communication and documentation skills.
  • Ability to work in a multi-disciplinary, collaborative manufacturing team with well-defined deliverables
  • Ability to follow verbal and written instructions
  • Basic computer skills and demonstrated ability to learn new systems and understand new technologies
Education and Experience:
  • Typically requires 1 year of experience or the equivalent combination of education and experience related to GMP manufacturing
  • Bachelor's degree in a scientific or technical discipline
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected].