- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- By providing a foundation for all operations company wide, our company’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases.
- Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology.
- Come join our team and make a meaningful impact on patients’ lives.
- Our company is a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
- A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills.
- The C&Q Engineer will serve as an integral member of the Facility Services Project team in a Biologics Drug substance manufacturing facility.
- The successful candidate will be able to demonstrate a proven track record to take systems from the Construction Handover stage and carry them through the Commissioning and Validation cycle and into Performance Qualification to allow handover to Manufacturing.
- The candidate is to be a convincing communicator with strong interpersonal skills to lead a team of Commissioning and validation engineers.
- This candidate will be required to work closely with a cross-functional team and coordinate activities between Manufacturing, Quality and Validation.
- Lead and coordinate a commissioning and qualification program, incorporating utilities, upstream and downstream manufacturing equipment and support services such as autoclaves, parts washers and cold rooms.
- Assist the commissioning manager in the planning and tracking of activities.
- Liase with the various stakeholders on the commissioning team and the overall project to ensure clear communication between all parties.
- Provide technical process support to the commissioning team throughout the project life cycle.
- Oversee the generation, execution and approval of Commissioning & Qualification documentation.
- Generate change controls and drive their closure in a timely manner
- Responsibility for direct supervision of vendor engineers and contractors during C&Q activities.
- Use of permit to work system or other safety systems to control commissioning activities.
- Participation in HAZOP and design reviews
- Deliverables such as technical specifications and vendor turnover documentation
C&Q Engineer has scope to initiate process, cost and continuous improvement ideas.
EDUCATION AND EXPERIENCE
- Minimum of an Engineering Degree with 8+ years experience working as a C&Q engineer in a Bio-Pharmaceutical or equivalent type industry
- Demonstrated experience in leading qualification systems
- Technical knowledge of utilities, upstream & downstream equipment ,biotechnology processes and a working knowledge of FDA and EU regulations is preferred