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Validation/cqv engineer

Melbourne
SeerPharma
Posted: 14 June
Offer description

Get AI-powered advice on this job and more exclusive features.Direct message the job poster from SeerPharmaDirector at SeerPharma - Advancing Quality and GMP Best Practices for the Pharmaceutical and Medical Device industriesCompany DescriptionSeerPharma's mission is to advance Quality and GMP Best-Practices to Pharmaceutical and Medical Device companies in the Asia-Pacific region. We look to achieve this by offering training, consulting, software, and contract employment services addressing the Quality and GMP compliance issues companies face. SeerPharma has assisted firms involved with and/or conducting step(s) of manufacturing pharmaceuticals and medical devices for over 35 years. We have an outstanding history of successful work with a broad client base across the APAC region and a great team of over 30 consultants and trainers assisting with a vast cross-section of the major international standards, including PIC/S, FDA, EU, WHO, and ISO.We have a friendly and inclusive culture, and testimony to this is the length of time our staff stay at SeerPharma. It is also an excellent opportunity to increase the breadth and depth of your knowledge, due to the variety of work we do.A Contractor position has arisen for a self-motivated Validation/CQV Engineer to join the SeerPharma Engineering Compliance team. This role is pivotal as SeerPharma has secured several major projects and has a pipeline of large facility projects in the Pharmaceutical and Medical Device industries.The successful candidate will have a strong understanding of Cleanroom design, including HVAC design requirements for cleanrooms in accordance with PIC/S GMP principles, plus demonstrate a willingness and initiative to learn from our current team of experts.The role will report to the Engineering Compliance Manager, and be primarily located in Melbourne or Sydney with flexibility for some remote work.Key Responsibilities:· Plan, author and execute GMP Facility Qualification protocols – DQ, IQ, OQ, PQ.· Contribute to GMP Facility Design Reviews, and responses to technical queries· Perform GMP Facility site inspectionsKey Personal Attributes:· Pragmatic and technical based approach· Excellent technical writing skills· Proficient in Microsoft Word· Ability to work efficiently within a defined scope of work· Ability to multi-task and adjust to a change in priorities· Ability to work within a team, as well as independently· Open to travel and working on-siteRequirements:· Engineering Tertiary Qualification· 5+ years of relevant experience· Proven track record in GMP Facility Qualification / CQV within the pharmaceutical, life science or medical device· Strong understanding of PIC/S requirements for Facility design, operation and qualification· Understanding of ISO 14644 Part 1,3 & 4 requirements.· Practical understanding of HVAC design for cleanrooms, and cleanroom designSeniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeContractJob functionJob functionQuality AssuranceIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at SeerPharma by 2xGet notified about new Validation Engineer jobs in Melbourne, Victoria, Australia.Melbourne, Victoria, Australia 3 weeks agoMelbourne, Victoria, Australia 2 weeks agoPort Melbourne, Victoria, Australia 4 weeks agoPharmaceutical Commissioning Qualification Validation EngineerMelbourne, Victoria, Australia 1 week agoClayton South, Victoria, Australia 3 weeks agoMelbourne, Victoria, Australia 4 days agoQuality Environment Health Safety EngineerMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 1 week agoCommissioning Qualification Validation EngineerMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 1 week agoSenior Pharmaceutical Commissioning Qualification Validation EngineerMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 10 hours agoMelbourne, Victoria, Australia 1 week agoComputer System Validation (CSV) Specialist (6 Months Contract)Melbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 3 days agoWireless Network and Validation EngineerPort Melbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 4 weeks agoMelbourne, Victoria, Australia 2 weeks agoDocklands, Victoria, Australia 2 weeks agoDocklands, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 4 weeks agoMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 6 days agoMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 14 hours agoBayswater, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 2 hours agoMelbourne, Victoria, Australia 1 year agoMelbourne, Victoria, Australia 13 hours agoMelbourne, Victoria, Australia 3 days agoMelbourne, Victoria, Australia 5 hours agoMelbourne, Victoria, Australia 3 weeks agoWe’re unlocking community knowledge in a new way. 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