CQV Engineer

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Location: Midlands

Type: Contract

Rate: Negotiable

Contact: roconnor@asset.ie

Reference: CQV

Updated: 20/10/2017 16:48:46


Commissioning & Qualification Engineers Fill Finish
(Lead’s + senior and Junior Engineers)
Midlands
Contract – Excellent hourly rate
12 – 24 months +
New Build – Pharma
Asap or within one month

Job Summary
The candidate will be required to work within a cross-functional team structure requiring the coordinate of activities between Manufacturing, Quality and Validation
Fill Finish

Skills Required:
Minimum of an Engineering Degree in a relevant discipline.
Minimum of 2 yrs. experience working within the regulated Pharmaceutical industry.
Experience in leading qualification of utility and equipment systems.
Technical knowledge of utilities, upstream & downstream equipment, biotechnology processes and a working knowledge of FDA and EU regulations.

Main Duties:
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.
Liaise 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.


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