Overview
This is an opportunity to be part of a dynamic team within the Engineering and Maintenance function, supporting our vision to be the most valued global provider of high-quality, competitively priced pharmaceutical products and provide excellent services and support to our customers.
Reporting to the Engineering Manager – Projects & Compliance, the Project Engineer will apply strong fundamental engineering expertise in support of design, commissioning, and qualification of pharmaceutical equipment and building utilities within our site. Effective management of projects ensuring compliance with GMP and regulatory requirements.
Key Responsibilities:
* 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
* Development and execution of FAT/SAT and commissioning qualification plans
* Management of projects to agreed timelines and costs. Projects entail capital facility and equipment alterations and additions.
* Ensuring project compliance with environmental, health, and safety standards
* Maintaining compliance to documented procedures and cGMP requirements to the highest possible standards
* Achievement of KPI's as outlined in Performance and Development Plan
* Leading project assignments and supervising outside contractors in compliance with company guidelines
Qualifications:
* Bachelor's degree 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 independently and as part of a team
* Demonstrated initiative and self-starter
* Experience using AutoCAD software package is also desirable