Validation Engineer, Delta Laboratories, Gosford & Central Coast NSWÂ
Delta Laboratories is an established contract manufacturer of cosmetic, veterinary and pharmaceutical liquid based products.
We are currently looking for an experienced Validation Engineer to join our team. Reporting to the General Manager, the purpose of this role is to coordinate validation activities across site and ensure compliance with TGA and APVMA requirements. This role will personally manage facility, utility and equipment qualification programs and provide oversight for all other validation groups. This role will support capital projects and efficiency/productivity improvements.
Specifically this role will be accountable for
- Managing the site Validation Master Plan across different functional groups
- Managing the qualification program for the facility, HVAC, water systems and computerised systems.
- Managing the qualification program for critical equipment including sterilizers and filling equipment
- Drive the implementation of process automation, control systems and line integration
- Actively seek out new technologies that improve business processes
- Document, review and coordinate User Requirement Specifications (URS’s), Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ)
Key capabilities required for the role:
- Strong problem solving and critical thinking capability with preparedness to involve others in finding a solution.
- The ability to effectively prioritise projects and manage your time based on the greater benefit to the business.
- Strong written and verbal communication skills with the ability to clearly articulate technical and non-technical requirements.
- Strong analytical skills with the ability absorb and interpret large amounts of information and document appropriately
- High attention to detail to ensure quality is maintained and all requalification’s, calibrations and projects meet regulatory standards and requirements.
For more information please contact Colin Wishart on 02 4340 0200. To apply in confidence please follow the links below.