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 SOP’s.
- 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 company’s 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:
- Bachelor's 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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Pay Range:
$104,000 - $156,000
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
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.
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