GxP Site Engineering Senior Specialist

Vertex Pharmaceuticals Inc (US); United States; Vor Ort; EUR 90.000 - 136.000; Vollzeit

Zusammenfassung

Vertex Pharmaceuticals Inc. (US) is seeking a GxP Site Engineering Senior Specialist to represent Global Engineering for facility, process, instrumentation, and regulatory needs at Vertex GxP facilities.

You will collaborate with Facilities Operations, Advanced Manufacturing Engineering, Project Engineering, PMO, CMC teams and site leadership to meet facility and manufacturing needs. The role involves various equipment and infrastructure-focused engineering efforts, design reviews, lifecycle

Qualifikationen

• Knowledge of cGMP and regulated facility design, change control, commissioning, qualification, validation.
• Experience with capital projects and process/facility equipment.
• Strong communication and teamwork across cross-functional groups.

Aufgaben

• Collaborate with scientific groups to understand evolving science and technology.
• Execute change management for facilities and related systems including commissioning.
• Lead design reviews for capital projects to optimize cost, efficiency and compliance.
• Prepare and review system lifecycle documents (P&IDs, I&C diagrams, user specs, CQV, SOPs).

Kenntnisse

GxP knowledge

Facility design

Regulatory compliance

Capital projects

Change management

Ausbildung

Bachelor's degree in Chemical/Mechanical/Electrical Engineering

Jobbeschreibung

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.
• #LI-Onsite #LI-AA1

Pay Range & Disclosure Statement

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.

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 [e-mail] Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.