Project Engineer

GSK; King of Prussia (PA); Vor Ort; USD 110.000 - 170.000; Vollzeit

Zusammenfassung

GSK in Upper Merion, PA is seeking a Project Engineer/Manager to oversee up to $2m of capital across multiple manufacturing projects. You will lead design, installation, qualification and validation of process equipment and utilities, coordinating internal and third-party resources to meet scope, budget and schedule.

You will ensure compliance with cGMP, PMF, and site EHS standards, while supporting tech transfer from development to manufacturing in a multi-disciplinary environment.

Qualifikationen

• BS in Engineering or Life Sciences required.
• 2+ years in a cGMP or FDA-regulated pharmaceutical environment OR 2+ years in project/process engineering.

Aufgaben

• Lead/design and install new or modified process/utility systems (bioreactors, chromatography, depth filtration, UFDF).
• Demonstrate strong project management (schedule, cost, communications).
• Ensure compliance with Engineering Standards, GSK policies, cGMP, PMF and regulatory requirements.
• Coordinate with customers and teams to define scope and execution plans.
• Oversee engineering activities from implementation to handover, including third-party firms.
• Develop commissioning/validation documentation with Validation Group and implement validation plans.
• Stay current with biopharm tech developments and support tech transfer to manufacturing.
• Track project status and changes with all stakeholders.
• Apply site safety procedures and EHS standards to ensure safe construction/demolition activities.

Kenntnisse

Construction Management

Data Integrity

Design Management

Digital Fluency

GxP Regulations

Lean Management

Manufacturing Technologies

Pharmaceutical Manufacturing

Problem Solving

Project Schedule

Risk Awareness

Scope Management

Ausbildung

BS in Engineering or Life Sciences

Jobbeschreibung

This role will manage up to $2m of capital across multiple projects involving commercial-scale process equipment and manufacturing suites. Responsibilities are inclusive of project management, design, installation, qualification, and improvement of equipment and facilities in an EHS- / Regulatory- / GEP-compliant manner at the Upper Merion GSC Biopharm site.

Responsibilities

• Lead and/or participate in the design and installation of new, or modifications to existing, process and/or utility systems, including bioreactors, chromatography skids, depth filtration skids, UFDF skids, etc., to meet technical, budget, and schedule goals.
• Demonstrate good project management skills (schedule, cost, communications) and coordinate outside and internal resources to safely execute projects in a timely and cost-effective manner.
• Ensure projects are completed in compliance with applicable standards, policies, and regulations (Engineering Standards, GSK policies, cGMP, Project Management Framework (PMF) and other regulatory requirements).
• Lead discussions and recommend solutions with key customer groups in order to gain a consensus on project scope and execution plan.
• Be personally responsible for the coordination of all Engineering activities from implementation to handover to customer for a given project, including management of third party engineering firms and/or trades.
• In cooperation with the Validation Group, develop commissioning and validation documentation, including test protocols, and implement validation plans on new process and utility systems and changes to existing systems, in order to maintain the validated status of existing systems.
• Stay current with developments in the field of biopharm technology. Support the transfer of technology from development into manufacturing.
• Follow up on projects’ status and arising issues/changes with all relevant parties (customer, finance, procurement and engineering departments).
• Be fluent in site safety procedures (LOTO, PTW, etc) and engineering standards to deliver projects aligned with EHS and engineering compliance requirements. Apply corporate EHS standards related to employee’s safety during construction/ demolition processes to achieve zero reportable injury rate, with continuous supervision and control on contractors’ activities.

Basic Qualification

• BS in Engineering or Life Sciences
• 2+ years of experience working in a cGMP or FDA regulatory Pharmaceutical environment
• OR 2+ years of experience in project and/or process engineering experience

Preferred Qualification

• Demonstrated ability to manage projects to completion on time and within budget.
• Familiar with cGMPs and GEPs for large scale biological processing.
• Must be able to interact well with peers, subordinates, and senior personnel in scientific, engineering, and operational disciplines.
• Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams.
• Project experience in the design, construction, start-up and operation of large bulk biopharmaceutical facilities including cell culture, or protein recovery and purification.
• Experience in Design, Installation, and Commissioning / Qualification / Validation
• Sense of Urgency / Decision making.
• Strong interpersonal skills.
• Must be able to work within a multi-disciplinary team environment.
• Must be able to generate options to resolve problems, prioritize solutions and implement decisions.
• Must be competent in handling simultaneously occurring tasks and smaller projects, and have excellent written and oral communication skills.
• Good Computer Skills (MS Office, MS Projects).
• Project Management Professional Program Certification or Professional Engineer license (Preferable).
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Skills

Construction Management, Data Integrity, Design Management, Digital Fluency, GxP Regulations, Lean Management, Manufacturing Technologies, Pharmaceutical Manufacturing, Problem Solving, Project Schedule, Risk Awareness, Scope Management.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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