Engineering Project Lead
Job Summary
The Engineering Project Lead will oversee change management and engineering projects within a pharmaceutical manufacturing environment. You will coordinate technical upgrades, facility improvements, and process enhancements while ensuring compliance with GMP standards. This role requires collaboration across cross-functional teams to drive operational excellence and project delivery.
Responsibilities
- Lead engineering change control activities
- Manage equipment and facility upgrade projects
- Partner with cross-functional teams for project execution
- Ensure compliance with GMP and regulatory standards
- Drive continuous improvement in manufacturing performance
Required Skills
- Degree in Engineering
- GMP and Change Control knowledge
- Project Management principles
- Technical documentation proficiency
- Stakeholder management
Job Details
Key Responsibilities:
- Lead and coordinate engineering change control activities from initiation through implementation and closure.
- Manage equipment upgrades, facility improvement projects, and manufacturing enhancement initiatives.
- Partner closely with production, quality, validation, maintenance, and external stakeholders to ensure successful project execution.
- Conduct technical assessments, risk evaluations, and impact analyses for engineering and process changes.
- Prepare, review, and maintain project documentation in compliance with GMP and regulatory requirements.
- Coordinate project timelines, resources, vendors, and site activities to achieve key deliverables.
- Support commissioning, qualification, and validation activities where required.
- Ensure all engineering activities adhere to safety, quality, and regulatory standards.
- Identify and implement continuous improvement opportunities to enhance manufacturing performance, equipment reliability, and operational efficiency.
Requirements:
- Degree in Mechanical Engineering, Electrical Engineering, or a related Engineering discipline.
- Experience within pharmaceutical, biotechnology, chemical, medical device, or other regulated manufacturing environments will be advantageous.
- Familiarity with GMP requirements, change control processes, and engineering project management principles.
- Strong communication, coordination, and stakeholder management skills.
- Ability to manage multiple projects and priorities effectively in a fast-paced environment.
- Proficient in Microsoft Office applications and technical documentation practices.
- Detail-oriented, proactive, and able to work independently as well as within cross-functional team.