We are seeking a highly motivated Project Engineer to join our Product Transfer & Tech Transfer team. This role is essential in supporting the PMO responsible for transferring product manufacturing across global sites. The ideal candidate will lead and coordinate engineering projects, ensuring delivery on time and within budget, while adhering to safety, quality, and regulatory requirements. The role requires project management experience, validation documentation expertise, and the ability to travel internationally.
Key Responsibilities:
General Activities:
- Lead and deliver engineering projects, ensuring they meet timeline, budget, safety, and quality goals.
- Scope new engineering projects and secure capital approval.
- Lead, support, and participate in commissioning and qualification activities for both current and future projects.
- Provide updates and influence management and key project stakeholders.
- Coordinate specialist trades, departments, and third parties (suppliers, customers, service providers).
- Oversee project interfaces between different teams, projects, and external partners.
- Manage project documentation, ensuring accuracy and compliance.
- Handle cost estimation (tracking, updating, auditing, and forecasting).
- Develop and maintain project schedules (tracking, updating, reviewing, forecasting).
- Report project progress and manage associated risks.
- Conduct constructability, maintainability, and operability studies.
- Manage project resources effectively.
- Assess and ensure system compliance (structural, E&I, safety, permitting, and documentation).
- Conduct retrospective project performance reviews and implement lessons learned.
- Participate in and lead cross-functional teams as required.
Scope of Responsibilities:
- Ensure safe execution of job activities, adhering to environmental and regulatory best practices.
- Perform both routine and non-routine tasks as delegated by the manager.
- Maintain compliance with corporate, cGMP, and EHS regulatory requirements.
- Follow engineering and site procedures, ensuring documentation meets GDP standards.
- Prioritize and schedule tasks to align with business needs.
- Complete personal training in compliance with site procedures.
- Provide support to Operations, Quality Validation, MSAT, Facilities, and other functions.
- Represent the company in external site visits for project-related activities.
- Lead by example and maintain high-performance standards.
Required Qualifications & Experience:
- Bachelor's or Masters degree in Engineering, Science or related discipline.
- 3-4 years experience in a similar role within a GMP regulated environment.
- Prior experience working within Medical Devices will be an advantage.
- Strong understanding of validation documentation: IQ, OQ, PQ, FAT, SAT, URS (editing/approving experience required, not creation).
- Ability to analyze data and statistics for project tracking and decision-making.
- Willingness to travel internationally once a month.
