GxP Site Engineering Senior Specialist

Job Description

General Summary:

The GxP Site Engineering Senior Specialist will represent Global Engineering for Engineering needs from process facility instrumentation and regulatory needs for Vertex GxP Facilities. The GxP Site Engineering Senior Specialist will collaborate with Facilities Operations Advanced Manufacturing Engineering Project Engineering PMO CMC teams and Site Leadership to meet all facility and manufacturing needs. This role will involve various aspects of equipment and facility infrastructure-focused engineering efforts.

Key Duties and Responsibilities:

• Collaborate with scientific groups to learn and understand the evolving science and technology.
• Executes change management for facility and other support systems including commissioning and/or implementation of other related initiatives as assigned.
• Implement science centric strategic decisions for capital projects based on scientific knowledge education and experience.
• Participate in design reviews for various capital projects and new equipment with cost efficiency and compliance always in mind.
• Creation revision and review of system lifecycle documentation. This includes but not limited to engineering drawings and design documents reports P&IDs user requirements specifications CQV documents (commissioning protocols IOPQs) and SOPs.
• Perform engineering assessments for new capital equipment/projects.
• Provide SME support for regulatory inspections from facility design and engineering standpoint.
• Influence peers to consistently implement continuous improvements to existing and new facilities/equipment.
• Collaborate to ensure all Engineering KPIs are appropriately monitored tracked and reported.
• Lead and participate (as needed) in troubleshooting of process equipment facility equipment and associated utilities to resolve any observed discrepancies.
• Work collaboratively with Manufacturing Process/Analytical Development R&D groups EH&S Capital Project Management DTE QA Advanced Manufacturing Engineering Project Engineering and others to support the consistent achievement of the companys strategic objectives.
• Cultivate change and innovation by seeking opportunities to strengthen and improve existing engineering services.

Knowledge and Skills:

• Knowledge of cGMP and regulated facility design change control processes compliance requirements commissioning qualification validation and best practices in the pharmaceutical industry.
• Experience with Cell and Gene Therapy Oral Solid Dose or Biologics facility design
• Ability to read interpret and redline engineering drawings (P&IDs I&C Diagrams Electrical Panel Schedules etc.) and be able to perform engineering calculations
• Understanding and application of technical principles theories and concepts in the field and familiarity with industry best practices and standards (GMP GEP ISO GAMP BPE ISA ANSI etc.).
• Knowledge of facility related engineering disciplines (MEP) in GMP manufacturing environment.
• Familiarity with GMP manufacturing regulations such as applicable FDA 21 CFRs
• Developed verbal and written communication skills and interpersonal skills to explain complex information to others in a straightforward fashion.
• Strong interpersonal skills including the demonstrated ability to manage through influence.
• Must exhibit mechanical abilities including tool familiarity lifting climbing a ladder and gowning into cleanrooms.
• Candidate must be responsive to change and adapt quickly to changing circumstances.
• Must demonstrate effective self-management and act on improvement opportunities.

Education and Experience:

• Bachelors degree in Chemical Mechanical or Electrical Engineering or a related discipline
• Typically requires 3-6 years of relevant work experience in GxP Engineering; OR any equivalent combination of experience and/or education from which comparable knowledge skills and abilities have been achieved.

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At Vertex we embrace continuous learning and encourage employees to stay informed on advances in AI technology automation and industry trends. We seek talent who bring an external perspective demonstrate curiosity and sound judgment and thoughtfully adopt new capabilities that improve decision-making drive innovation increase efficiency and help deliver better outcomes for patients.

Pay Range:

Disclosure Statement:

Flex Designation:

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 Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

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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 persons 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