Project Engineer

Project Engineer

Role 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 the companies 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.

Responsibilities include:

* Management of engineering and capital projects, ensuring compliance with GMP standards.

* Drafting user requirement specifications for machinery/equipment and reviewing vendor designs/specifications.

* Development and implementation of FAT/SAT and commissioning qualification plans.

* Managing projects within agreed timelines and budgets, including capital facility and equipment

* Maintaining compliance with documented procedures and cGMP requirements at the highest standards.

* Meeting KPIs as detailed in the Performance and Development Plan.

* Leading project tasks and overseeing external contractors according to company policies.

Competencies:

* 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

* Management of projects to agreed timelines and costs. Projects entail capital facility and equipment alterations and additions.

* Lead project assignments and supervise outside contractors in compliance with company guidelines.

* Experience in a cGMP Manufacturing and or Biotechnology, pharmaceutical or medical device company is desirable