Specialist Manager (Pharmaceutical Validation Lead)
- Exciting new opportunity
- Broad responsibilities
- Wellington based
Ready to join an organisation that is growing in 2019?
At Fitzroy Engineering Group Limited, we are dedicated to providing quality solutions for our clients across the pharmaceutical and industrial sectors.
We are currently looking for an experienced Validation Lead to support the major expansion of our client's animal health vaccines manufacturing plant.
In this role you will:
- Provide high level governance in enabling effective and timely Validation activities to support the clients major expansion
- Lead the integrated Validation of projects, both "Brown field" and "Green field"
- Define and document the appropriate regulatory basis for projects, enabling manufacture of animal health products for sale worldwide
- Manage Validation activities such that they are fully integrated with the project approach and the engineering delivery of the facility
We are looking for the following experience and competencies:
- A tertiary qualification in Biological Sciences is required
- Experience in a QA / Validation Lead role within vaccines manufacturing environment - in an "operating" and or / "projects" role
- Experience leading a Validation team
- Experienced in qualifying the variety of systems common place in pharmaceutical manufacturing e.g. SIP, CIP, Autoclaves, Fermentation Plant, DSP (i.e. Centrifugation, UF), Cleanrooms (HVAC), Clean Utilities, Computer systems
- Detailed working knowledge of, and practical application of GMP standards applicable to manufacture of parenteral products in NZ, ASME BPE, ISPE Baseline and Best Practice Guides, GAMP
In return, we offer:
- Competitive salary and benefits that include extended annual leave for long service and discounted medical insurance
- Ample opportunity to further develop your career through on-job skill development, and access to relevant certified training
- Job security and a safe work environment
If you are seeking an exciting opportunity in 2019 where your passion for delivering high quality Validation solutions, in the pharmaceutical sector, is recognised and rewarded, this could be the opportunity you are looking for.
If you are confident you have what it takes please apply with your CV and cover letter today!