Manufacturing Operations Specialist
Semma Therapeutics
Job Description
General Summary:
Vertex Pharmaceuticals Inc. has established a state-of-the-art GMP manufacturing facility in Boston less than a mile from the Corporate Headquarters in the Seaport District. This GMP facility is a keystone to delivering our strategy of bringing transformative medicines to patients in need, from clinical development to commercialization.
The Specialist will be responsible for supporting manufacturing for all phases of small molecule solid oral manufacturing pre-purchase, qualification, development, and clinical and commercial manufacturing. This position may require working extended or alternate hours or overtime depending on the manufacturing schedule.
Key Duties and Responsibilities:
The primary responsibility of the Specialist will be to equipment readiness for oral dosage small molecule drug product using traditional manufacturing techniques including granulation, compression, and film coating and includes the following responsibilities:
- Identifying new equipment capabilities required for the facility
- Performing FAT, SAT, and qualification for new equipment
- Set up, Disassembly, Operation, and Troubleshooting of process equipment
- Functioning as a subject matter expert on manufacturing equipment and training others
- Participating and/or leading change controls, investigations, and CAPAs related to equipment
- Writing and revising documentation for manufacturing equipment including procedures and assessments
Knowledge and Skills:
- Ability to lift up to 50lbs, visual acuity, manual dexterity, and ability to distinguish between the colors red, yellow, blue, and green
- Ability to stand for extended periods of time
- Knowledge of CGMP requirements for manufacturing
- Solid organizational, interpersonal, communication, and documentation skills
- Ability to follow written and oral instructions in English
- Basic computer skills and ability to learn new systems
Education and Experience:
Bachelor’s degree and 1 year of experience or the equivalent combination of education and experience in a related field
- This is a first shift position, Monday – Friday. Extended or alternate working hours may be required based on the manufacturing schedule.
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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 ApplicationAssistance@vrtx.com.