Biopharmaceutical Manufacturing Environment
Role Overview
An opportunity is available for an experienced Senior Project Engineer to support the design, specification, and commissioning of new and upgraded biopharmaceutical process equipment.
The role combines hands-on engineering delivery with project ownership, providing technical support and structured problem-solving for existing manufacturing processes and equipment.
This position plays a key role in supporting both capital projects and continuous improvement initiatives within a regulated GMP manufacturing environment.
Responsibilities
Design and specify c GMP-compliant process equipment, including associated piping and control systems.
Prepare and maintain Process Flow Diagrams (PFDs), Piping & Instrumentation Diagrams (P&IDs), and related engineering drawings.
Support equipment design reviews, factory and site acceptance activities, installation, and commissioning.
Project Execution
Manage small to mid-sized engineering projects related to process equipment and manufacturing improvements.
Develop engineering evaluations, test plans, and change control documentation.
Coordinate mechanical, electrical, and automation contractors during project execution.
Validation & Compliance Support
Support Quality and Validation activities through preparation of design documentation and execution of validation protocols.
Review and approve lifecycle documentation, cleaning validation protocols, and summary reports.
Ensure engineering solutions comply with GMP, safety, and regulatory requirements.
Operations & Continuous Improvement
Provide engineering support for investigations into equipment, utility, and control system issues.
Implement corrective and preventative actions to improve equipment reliability and process performance.
Support safety investigations and promote a strong safety culture within engineering and manufacturing areas.
Stakeholder Collaboration & Leadership
Represent engineering at cross-functional project and operational meetings.
Assist management with tracking departmental workload, throughput, and efficiency.
Provide supervision or technical guidance to junior engineers and contractors as required.
Candidate Profile
Technical Background
Strong engineering fundamentals with proven experience in regulated manufacturing environments.
Direct experience with biopharmaceutical or pharmaceutical process equipment is highly desirable.
Core Skills
Excellent analytical and problem-solving abilities.
Strong communication and collaboration skills across multidisciplinary teams.
Ability to manage multiple priorities in a fast-paced, regulated environment.
Continuous improvement mindset with attention to quality and compliance.
Qualifications & Experience
Bachelor's degree (or higher) in Chemical, Process, or Mechanical Engineering, or a related discipline.
Minimum of 5+ years' relevant engineering experience (industry experience may be considered in lieu of formal education).
Experience supporting GMP manufacturing operations and capital projects is preferred.
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