• Job Description

  Req#: REQ-21722

  Job Description

  General/Position Summary

  The qualified candidate in this role will be managing the newly developed function called the Advanced Manufacturing Engineering under the Global Engineering team. The position provides strategic partnerships with the CMC and Commercial teams to improve, optimize and launch new/existing products at internal and external manufacturing sites.

  This role will involve in various aspects of manufacturing, equipment, facility and infrastructure-focused engineering efforts for existing and new facilities, from conceptual to detailed design, procurement, startup, testing, and commissioning for on-going outsourced and insourced manufacturing operations.

  Key Duties & Responsibilities

  • Spearhead and influence strategic decisions collaborating with internal and external teams to scale and improve existing processes and transfer new products into manufacturing from facilities, equipment and utilities standpoint.

  • Steer and provide feedback to insourced and outsourced manufacturing partners by defining strategy and roadmap for investment in people, process, equipment and facilities to support rapid business growth for all modalities.

  • Manage AME resources championing manufacturing operational model to ensure maximum throughput, optimized equipment layout and material balance within internal assets and provide feedback to external assets.

  • Champion the development of PFD, UFD, P&IDs and models for new and evolving processes agnostic to modalities.

  • Lead the procurement efforts for cell and gene therapy CMC equipment from end (URS) to end (Release for use) to meet the associated department & program needs.

  • Manage manufacturing operational model to drive continuous improvements in manufacturing service levels to both internal and external customers.

  • Lead periodic review of the manufacturing assets to ensure optimization and cost reduction.

  • Work closely to the Quality team to ensure compliance during in house and external GMP manufacturing including strategies to successfully implement manufacturing or quality control method changes.

  • Lead science-centric strategic decisions for capital projects based on scientific knowledge, education and level of experience.

  • Participate in design reviews for various capital projects with awareness of cost, efficiency, sustainability and compliance.

  • Cultivate change and innovation by seeking opportunities to strengthen and improve existing engineering services.

  Required Experience

  • Bachelor's degree in Mechanical, Electrical, Civil, Industrial or Chemical Engineering, or a related discipline

  • Master's degree in Engineering or related discipline preferred but not required

  • Typically requires greater than 10 years of relevant work experience in manufacturing engineering; OR, any equivalent combination of experience and/or education from which comparable knowledge, skills, and abilities have been achieved

  Required Knowledge/Skills

  • Candidate must be responsive to change and adapt quickly to changing circumstances

  • Must demonstrate effective self-management and act on improvement opportunities

  • Developed verbal and written communication skills and interpersonal skills to explain complex

  • information to others in straightforward situations

  • Ability to navigate and be successful in a fast-paced, highly matrixed work environment

  • Knowledge of current applicable regulatory expectations

  • Experience supporting Research and Development in the Pharmaceutical, Biopharmaceutical or other regulated industry

  • Experience with the detailed design process as well as oversight of installation, startup, testing, and thorough commissioning of CMC equipment is required

  • Knowledge of cGMP and regulated facility design, change control processes, compliance requirements, commissioning, qualification, validation, and best practices in the pharmaceutical industry

  • Extensive experience with office and R&D facility design, including architectural elements, lighting controls, FF&E, specialty R&D equipment, etc.

  #LI-Onsite

  #LI-AR1

  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.

• About the company

  Vertex Pharmaceuticals, Inc. is an American biopharmaceutical company based in Boston, Massachusetts.

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