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:
- Performs Process Analytical Technology (PAT) Operator tasks during GMP manufacture
- Lead, write and review deviations and investigations for the Drug Product Facility, Facilities, Materials Management and the Kilo Lab. Support RSL deviations as necessary.
- Develop corrective/preventative action plans through root cause analysis of deviations
- Author and submit revisions to controlled documents in QMS in support of GMP Operations, including SOPs, WIs and MBRs
- Review executed batch records to ensure compliance with GDP/GMP requirements
- Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across GMP Operations.
Knowledge and Skills:
- Ability to follow verbal and written instructions
- Good communication and documentation skills.
- Ability to work in a multi-disciplinary, collaborative manufacturing team with well-defined deliverables
- Basic computer skills and demonstrated ability to learn new systems and understand new technologies
- Experience with manufacturing systems utilizing computerized control systems and HMIs
- Basic understanding of the cGMP framework in the context of both development and commercial pharmaceutical drug product manufacturing environment
Education and Experience:
- Bachelor's degree in a scientific or technical discipline
- 1 year of experience or the equivalent combination of education and experience related to GMP manufacturing
Flex Designation:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
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]
What We Do
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases.
We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development.
Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.
