Overview:
This is an opportunity to be part of a dynamic team within the Engineering and Maintenance function. We are looking for individuals who will support and drive our vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to 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
- 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.
