Job ID :
42139BR
Location :
New Zealand - Auckland
:
Job Description
Responsibilities
Skills, Experience and Education
We are looking for a permanent Validation Engineer at our Penrose facility in Auckland to support our manufacturing operations. This role performs calibration and validation of equipment and systems; develops procedures, protocols, methods, techniques and evaluation criteria for obtaining results; and is a part of quality improvement teams.
Responsibilities
- Ensuring a high level of conformance to the established quality systems (principles of ISO 9001 and cGMP)
- Developing, executing, managing and continuously improving the site master validation program, the calibration (metrology) program and engineering quality assurance systems
- Work closely with QA and senior manufacturing staff
- Assisting with Engineering and facilities responsibilities
- Interfacing with operational teams in resolving quality procedural and validation variances, as required
- Conceiving/leading/managing/participating in quality improvement initiatives associated with Validations and Engineering
- Maintaining a high level of cost stewardship
- Actively participating in customer and regulatory site audits, as required
- Champion the Engineering Validation function as a team and service based organisation in support of operations at the shop-floor level
- To carry out any reasonable tasks requested to improve the Company’s operations
Skills, Experience and Education
- Bachelor degree in a scientific/engineering discipline or equivalent
- Related experience as a validation technician in a rigorous cGMP or similar compliance environment, preferably in the biopharmaceutical, pharmaceutical industry, or diary industry
- Strong production process and/or manufacturing engineering background, with experience in process validations preferred
- Technical knowledge base in cGMP validation concepts and techniques
- Highly self-directed and results focused
- Excellent team and interactive skills
- Excellent written and oral communication
- High level of internal and external customer focus and responsiveness
- Experience in a cGMP environment
- Project management skills
