Senior Validation Engineer (Adelaide)

Senior Validation Engineer (Adelaide)

13 Aug
|
Noumed Pharmaceuticals
|
Adelaide

13 Aug

Noumed Pharmaceuticals

Adelaide

About Us:
Noumed Pharmaceuticals is a fast-growing pharmaceutical company specialising in generic and private label over the counter (OTC) medicines.
With its head office in Adelaide, South Australia, the company also operates from Melbourne and Auckland, supporting its focus on compliant, high-quality manufacturing aligned with current Good Manufacturing Practice (cGMP) standards.
As an emerging organisation in the pharmaceutical sector, Noumed is actively expanding its product portfolio and building a strong presence across Australia and New Zealand.
The company is driven by a commitment to innovation, quality, and accessibility, with a vision to grow into a competitive global player.
Noumed offers a unique environment shaped by growth, development, and collaboration.
The business continues to evolve rapidly, providing insight into the progression of a modern pharmaceutical company and the exciting trajectory of an organisation positioning itself for international expansion.
About You:
Minimum science degree in a science or engineering discipline.
Position Summary:
The Senior Validation Engineer plays a key role in the delivery and validation of the pharmaceutical manufacturing facility, with a strong focus on ensuring that facilities, utilities, manufacturing and packing equipment, and processes are appropriately qualified and validated in accordance with GMP requirements and applicable regulatory expectations.
This is a highly hands-on role, working directly with Engineering, Manufacturing, Quality, Project Management, contractors and equipment suppliers to develop, execute and close out validation activities.
The Senior Validation Engineer is responsible for developing and implementing the facility's validation strategy, including the preparation and execution of the Validation Master Plan (VMP), qualification protocols, validation reports and associated documentation.
The role has significant involvement throughout the lifecycle of the facility, from installation through commissioning, qualification, process validation and operational readiness.
Key Requirements:
Minimum of 7-8 years' experience in and understanding of pharmaceutical industry.
Experience in working in Quality (PIC/s) systems.
In depth knowledge of Good Manufacturing Practice (GMP).
Thorough knowledge of regulatory codes and regulations, in relation to manufacturing - PIC/S, TGA, MHRA.
Experience in validating facilities,



utilities and equipment, including but not limited to:
ISO Clean Rooms
HVAC and BMS.
Compressed Air Systems.
Purified Water generation and distribution systems.
Manufacturing and Packaging equipment associated with liquid and solid oral dose manufacturing.
Clean-in-place (CIP) systems.
Experience in process validation, cleaning validation and computer systems validation.
Exceptional attention to detail and quality documentation.
Ability to drive projects forward, involving multiple teams and managing key stakeholder expectations.
Ability to manage multiple projects simultaneously with a commitment to meeting deadlines.
Knowledge of OTC medicines.
Excellent oral and written communication skills.
Excellent organisational and planning skills.
Detailed knowledge of best practice from Manufacturing and Quality perspective.
Additional
Strong Microsoft Office skills, including Excel, Word and PowerPoint.
Project management knowledge and experience.
Ability to think critically and outside the box.
Solid attention to detail and documentation quality.
Good interpersonal skills.
Ability to work independently.
Ability to remain calm and objective in a pressurised, results-driven environment while managing changing and conflicting priorities.
Job Responsibility:
Develop, maintain and implement the sites validation master plan (VMP) of the new manufacturing facility.
Establish validation strategies, priorities, acceptance criteria and documentation requirements for all facilities, utilities, equipment and processes.
Develop validation schedules aligned with the overall project and facility start-up schedule.
Provide ongoing validation input into project design, procurement, installation, commissioning and start-up activities.
Participate in design reviews, risk assessments, supplier assessments and technical reviews to ensure validation requirements are incorporated from the outset.




Ensure validation activities are appropriately risk-based and aligned with GMP requirements and company procedures.
Work closely with Engineering, Quality, Manufacturing and Project teams to ensure validation activities support the overall facility delivery timeline.
Prepare and execute validation protocols for facilities, utilities and equipment as required.
Prepare and execute validation protocols for all process validation and cleaning validation activities.
Writing of validation reports and other technical documents.
Active participation in change control process.
Job Benefits:
At Noumed Pharmaceuticals, we are committed to supporting the professional development, health and wellbeing of our employees.
As part of our team, employees have access to a range of benefits, including:
Flare Benefits Platform – Access to a wide range of employee benefits, exclusive offers and discounts across everyday expenses, including groceries, retail, entertainment, travel, dining and more.
Onsite Gym Facility – Complimentary access to our onsite gym, supporting employee health, fitness and wellbeing.
Paid Wellbeing Leave – One additional paid Wellbeing Day each year, providing dedicated time away from work to focus on personal health and wellbeing.
Training & Professional Development – Company-supported training and development opportunities to build professional capability, technical expertise and support ongoing career development.
Free Onsite Parking & EV Charging – Complimentary onsite parking for employees, including access to electric vehicle charging facilities at no cost.
Skilled Growth & Development – The opportunity to develop your expertise and contribute to a growing Australian pharmaceutical manufacturing operation.
New Pharmaceutical Manufacturing Facility – The opportunity to play an integral role within a new pharmaceutical manufacturing facility and contribute to its validation, operational readiness and transition to commercial manufacturing.
Collaborative, Cross-Functional Environment – Work alongside experienced professionals across Engineering, Quality, Manufacturing, Supply Chain and other key business functions.
Long-Term Career Opportunity – Join a growing pharmaceutical organisation and contribute to the continued development and expansion of its Australian operations.
Play a key role in the validation and operational readiness of a new pharmaceutical manufacturing facility.

📌 Senior Validation Engineer (Adelaide)
🏢 Noumed Pharmaceuticals
📍 Adelaide

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