GXP Operations Support Specialist

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:

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]