Biopharma Capital Projects Engineer

GSK; King of Prussia (PA); In loco; USD 110.000 - 170.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

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

Mansioni

• 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.

Conoscenze

Construction Management

Data Integrity

Design Management

Digital Fluency

GxP Regulations

Lean Management

Manufacturing Technologies

Pharmaceutical Manufacturing

Problem Solving

Project Schedule

Risk Awareness

Scope Management

Formazione

BS in Engineering or Life Sciences

Descrizione del lavoro

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.