BioMarin 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. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
C&Q Engineer – Temporary 8 Month Contract Position
BioMarin are 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
Work cross functionally to deliver systems/projects for internal customers or as part of a multidisciplinary project team.
Work with Engineering firms and contractors for design, construction and C&Q activities.
Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.