Process Validation Manager

Work Schedule

Environmental Conditions

Job Description

The network of drug substance manufacturing sites includes St. Louis USA Lengnau Switzerland Groningen Netherlands and Brisbane Australia. The success of the network relies on each site to introduce and validate commercial processes remaining compliant with international quality requirements as defined by TGA FDA EMA and other regulatory agencies as applicable.

You will lead Process Validation (PV) Cleaning Validation and Continued Process Verification (CPV) efforts for the Brisbane site utilising the lifecycle approach in accordance with the Site Validation Master plan client-specific Validation Plans and within the Quality System. As Manager Process Validation you will uphold Customer Allegiance (CAS) quality of work (Right-First-Time - RFT) and On-Time Delivery (OTD) for Validation activities while ensuring product quality robust processes and regulatory compliance.

You will train and mentor staff and contribute to the global Process Validation network supporting and driving harmonisation. You will be seen as the Process Validation point of contact for the site speaking with authority on matters that may impact the validated state of commercial processes or cleaning processes to internal and external stakeholders.

Key Responsibilities:

• Process Validation Lead for the site upholding CAS RFT OTD and compliance for the Process Validation team.

• Manage develop and mentor a team of customer-facing Engineers to deliver the site validation objectives.

• Manage all aspects of the Process Validation Team in accordance with current guidelines on Process and cleaning validation in compliance with regulatory bodies (e.g. TGA FDA EMA).

• Coordinates validation execution including training staff resourcing protocol execution activities and tracking progress. Ensures safe and compliant completion of validation projects per required schedules.

• Develop and maintain workload/resource plans and model workload to maintain sufficient staffing for client projects at Process Performance Qualification (PPQ) and commercial stages.

• Monitors and supports late-phase activities in preparation for PPQ including Process Characterisation (PC) risk assessment and any other preparative studies.

• Strongly collaborates with customers and Regulatory/CMC on filing strategy and content (e.g. BLA) for commercial market authorization.

• Prepares presents and defends the sites validation approach to regulatory agencies and coordinating responses to regulatory filing queries or requests.

• Ensures that site process validation practices meet regulatory and corporate requirements aligning site Quality with global guidance and procedures to incorporate the current standards for Process and Cleaning Validation.

• Support Global network PV/CMC strategy and tech transfer initiatives to enable network harmonization in PSG. Develop strategic vision for site Process Validation aligning global direction and site objectives.

• Coordinates team participation on Tech Transfer and capital projects. Leads Validation processes and activities. Assigns resources as required.

• Act according Patheon Corporate and Patheon Biologics guidelines systems and requirements;

• Up to 10% International travel

How will you get here

Education:

• Tertiary degree in Science or Engineering (preferably in biology biotechnology biochemistry chemistry)

Experience

• More than 5 years in a biopharmaceutical cGMP environment with large scale process and cleaning validation experience.

• Demonstrated mentorship/coaching experience (previous management experience is preferrable).

• Demonstrated success managing complex validation projects and programs (PPQ experience preferrable)

• Experience with validation planning and leveraging quality systems for control of change e.g. Trackwise.

• Experience authoring and reviewing technical documentation and regulatory submissions

• Experience with root cause analysis CAPA change control and deviation management

• Strong PPI / Continuous Improvement experience and track record in implementing significant change projects that adhere to key site strategic initiatives.

• Strong client-facing and audit-facing experience

Skills & Attributes:

• Strong knowledge of cGMP regulations and expectations for Process Validation from regulators particularly FDA TGA EMA.

• Excellent technical writing and documentation skills particularly with validation documentation.

• Expertise in risk assessment methodologies and statistical analysis including CPV.

• Ability to work in a matrix management system and influence across functions and levels.

• Effective planning resource and time management skills.

• Strong problem-solving capabilities and analytical thinking skills

• Strong interpersonal and communications skills; written and oral and a demonstrated decision-making ability.

• Proficient with IT systems including applications such as MS Office Project and knowledge of controlled documentation and data systems.

• Experience with data management systems (e.g. Discoverant).

Whats in it for you

• A competitive salary and performance related bonus structure

• Access to Thermo Fishers global University

• Development opportunities as part of a rapidly growing global organisation

Our Mission!

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us! As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Other Job Requirements:

Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.