Job Title : Process Scientist - Co.Offaly
Location : Tullamore, County Offaly
Company : Randstad Financial Services
Salary :
Open Date : 2023-04-13
Close Date : 2023-08-13

Process Scientist - Co.Offaly

If you would like to learn more about this opportunity please contact Isabel, our Life Science Specialist. [email protected]

Why work for this company?

Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services.

Company Profile:

• 65+ years of experience in animal health
• Nearly $6 billion annual revenues
• 25 manufacturing sites around the world
• 10,000 employees worldwide of which 1,100 employees are committed to RandD

Position Summary:

The Manufacturing Technology group is responsible for new product introduction, technology transfers, process validation, and continued process technical support to unit operations for the commercial manufacture of multiple processes in the facility. The successful candidate will be a key contributor to a dynamic and highly technical team and will be required to build collaborations with Process Development, Manufacturing, Engineering, Supply Chain, Quality Assurance, Quality Control and Global Regulatory groups. The position is accountable for the timely completion of technical transfer and process validation related milestones, PPQ, process monitoring and manufacturing support. Expertise in the design, control, and operation of the upstream and downstream processing unit operations.

Position Responsibilities:

• Support new product introduction, process technology transfer, process validation and the preparation of CMC documentation for regulatory filings. Owning and driving significant cross-functional scopes of work associated with the technical transfer of new products.
• Provide hands-on technical support for manufacturing process activities and support team input to investigations and resolution of process deviations, root cause analysis, CAPAs, process improvements, change controls and preparation of regulatory filings.
• Accountable for delivery of upstream and downstream technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process. Assists in evaluating process performance by comparing manufacturing data to historical data.
• Strong knowledge of cGMP compliance, site and regulatory agency requirements and provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.
• Participates in continuous improvement initiatives, action plans to implement operational excellence, and lean practices along with setting and maintaining department goals and metrics.

Candidate Requirements:

• BSc, MSc or PhD, in a relevant discipline (e.g biotechnology, biochemistry, process engineering) or equivalent experience.
• 2+ years experience in pharmaceutical manufacturing organisation and/or bioprocess development, with experience in upstream or downstream unit operations, process scale up, facility fit and process validation.
• Experience with large scale manufacturing support for mammalian cell culture, upstream and downstream processing, Single Use Systems, cGMP and US / EU regulations.
• Excellent verbal and written communications skills.
• Project management capability.
• Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
• Knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design and process control fundamentals in commercial manufacturing.
• Be proficient in ETS, SAP, Veeva Vault, strong knowledge of Excel, Word, and PowerPoint desirable.
• Strong strategic and analytical thinking, problem solving and rapid decision making skills.
• Experience in the design, modification and optimization of upstream and/or downstream processes.
• Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous/matrix environment.
• Understanding of project management systems and tools. Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
• Experience in process optimization, characterization and troubleshooting for manufacturing processes.

• Knowledge of Statistical Process Control, Computer Modelling, Data Analytics and related tools.

Randstad Financial and Professional encourage applications from individuals of all ages and backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial and Professional acts as an employment agency for permanent recruitment and an employment business for temporary recruitment as defined by the Conduct of Employment Agencies and Employment Business Regulations 2003

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