Senior Associate - Validation (New South Wales)

Senior Associate - Validation (New South Wales)

05 Aug
|
Parnell Manufacturing
|
New South Wales

05 Aug

Parnell Manufacturing

New South Wales

Parnell is on an exciting growth trajectory and we’re looking for a Senior Validation Associate to join our team at our Alexandria, Sydney manufacturing facility.

Reporting to the Validation Manager, you’ll be part of a close-knit team where no two days are the same. You’ll have the autonomy to own your work, the challenge of solving real problems, and the satisfaction of knowing that what you do every day directly contributes to animal health outcomes around the world.

WHAT YOU'LL BE DOING

The Validation team are seeking an experienced and reliable Senior Validation Associate with a solid background in validation within an FDA-regulated pharmaceutical or veterinary manufacturing environment. This role is suited to a candidate who can take ownership of the day-to-day execution of the validation program and excel!

Execute validation activities across process, equipment, cleaning, and computer systems in alignment with Validation Master Plans and regulatory requirements.

Develop and review qualification and validation documentation (URS, DQ, IQ, OQ, PQ, VP, VR) in accordance with compliance requirements and project timelines.

Support Continued Process Verification (CPV) and periodic revalidation to ensure processes remain in a validated state.

Develop and support metrics to monitor validation performance through data trending and statistical analysis.

Perform statistical analysis (e.g., process capability using Minitab) to verify and improve ongoing process performance.

Support process characterisation activities including CPP identification, control strategies, HACCP, and PFMEA.

Liaise with cross-functional teams (production, engineering, QA, QC) to support investigations, troubleshooting, and continuous manufacturing improvement activities.





Support the implementation and validation of MODA-ES (EBRs, eLogs) and MODA-EM digital systems, including full CSV lifecycle documentation and CFR Part 11 assessments.

Translate paper-based SOPs and batch records into electronic workflows, collaborating with internal teams, Lonza, and consultants across multiple time zones.

Ensure data integrity and Annex 11 compliance for digital systems, and support personnel training and audit activities related to digital systems.

ABOUT YOU

You are a proactive, quality-driven professional who takes pride in delivering results in a fast-paced, regulated environment. You will bring:

Degree in Engineering, Science, or a related discipline (Engineering highly advantageous)

3-5 years of relevant experience in the listed role or a related field

Demonstrated experience in validation within a GMP-regulated environment (FDA, APVMA, or equivalent), Process Validation, Equipment Qualification (IQ/OQ/PQ), Cleaning Validation, Computerised System Validation (CSV)

Experience working with Validation Master Plans (VMPs) and lifecycle validation approaches

Solid understanding of data integrity and regulatory expectations (e.g., FDA, ICH, Annex 11) - Exposure to Part 11 compliance and data integrity requirements

Experience supporting or implementing Electronic Batch Records (EBRs) or similar digital manufacturing systems





Ability to translate paper-based processes into structured electronic workflows

WHY PARNELL?

We’re not your average pharmaceutical company. Parnell is a globally operating animal health business on an upward trajectory and we’re building the team that will take us there.

You’ll matter here. As part of a close-knit, high-performing team, your contributions directly shape outcomes for the animals and customers we serve

You’ll grow your expertise in a regulated cGMP and sterile manufacturing environment, building skills that genuinely set you apart in the industry

You’ll be part of something meaningful, delivering animal health solutions that make a real, measurable difference to our customer’s success.

You’ll work alongside people who share your commitment to Professionalism, Excellence, Teamwork, and Safety and Sterility.

WHO ARE WE?

Parnell Veterinary Pharmaceuticals is a globally operating animal health company with a pharmaceutical manufacturing facility in Alexandria, Sydney, a facility in Menomonie, WI, and a dynamic corporate hub in Kansas City driving commercial operations, sales, marketing, digital technology, and corporate services.

We are passionate about pushing the boundaries of animal health partnering with veterinarians, producers, and pet parents to deliver innovative, differentiated solutions that create real, measurable improvements. Bold ideas and continuous improvement aren’t just welcomed here, they’re expected!

Parnell is an equal opportunity employer that values diversity and inclusion. We encourage candidates from all backgrounds to apply. Only successful candidates will be contacted for interview.

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📌 Senior Associate - Validation (New South Wales)
🏢 Parnell Manufacturing
📍 New South Wales

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