Overview:
This is an opportunity to contribute to a dynamic team within the Engineering and Maintenance function, supporting our vision to be a global provider of high-quality pharmaceutical products at competitive prices, with excellent services and support for customers.
Reporting to the Engineering Manager – Projects & Compliance, the Project Engineer will apply fundamental engineering expertise to support design, commissioning, and qualification of pharmaceutical equipment and building utilities within our site, ensuring compliance with GMP and regulatory requirements.
* Management of engineering projects, capital projects, compliance to GMP standards
* Preparation of user requirement specifications for various machinery/equipment and review of vendor designs/specifications
* Develop and execute FAT/SAT and commissioning qualification plans
* Management of projects to agreed timelines and costs. Projects entail capital facility and equipment alterations and additions
* Ensure Project compliance with environmental, health and safety standards
* Ensure compliance to documented procedures and cGMP requirements are maintained to the highest possible standards
* Achievement of KPI's as outlined in Performance and Development Plan
* Lead project assignments and supervise outside contractors in compliance with company guidelines
QUALIFICATIONS:
* BS in Engineering or other technical discipline
* Minimum of 3 years engineering experience
* Experience in a cGMP Manufacturing and or Biotechnology, pharmaceutical or medical device company is desirable
* Ability to work on own and as part of a team
* Demonstrated initiative and self-starter
* Experience using any of the following AutoCAD software package is also desirable