Description
Role: Process Validation Scientist/Engineer - Contract
My client are a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. They are the global leader in complement inhibition, and has developed and markets a number of treatments for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Their drug is currently approved in more than 40 countries for the treatment of PNH, and in the United States and European Union for the treatment of aHUS. They are evaluating other potential indications for their drug and are pursuing development of other innovative biotechnology product candidates in early stages of development. Further information about my client can be available on request.
Location: Athlone/Cork
Duration: 18 Months Initially
Rate: Can be disclosed at request
Principal Responsibilities
- Leading validation projects/activities such as media fills, process validation batches, re-qualification activities etc. Collaboration with Quality, Safety, Operations, Facilities and Engineering, Supply Chain and Regulatory Affairs.
- Process mapping and gap analysis
- Project planning and execution including scheduling, task management, milestone planning and reporting.
- Delivering projects on time and on budget.
- Become Validation SME on site
- Review of equipment specification/design/procurement/installation and validation.
- Generation, review and approval of project documentation (User Requirement Specifications, validation protocols, reports etc) and Standard Operating Procedures.
- Support validation activities for project activities including review of validation documentation
- To facilitate and participate in meetings and workshops as part of Continuous Improvement activities.
- To approve plant SOPs and other documents as required, ensuring the acceptability of content and format.
- Working with the Validation Manager to define the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency.
- Accountable for compliance via documentation completion, risk assessments, review of protocols and reports, closing out preventative and corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
- Supporting the execution of filter validation, polymeric contact material qualification, container closure integrity validation and Media Fills where required.
- Support and liaise with Technical Services in relation to the tech transfer of products into the facility.
- Supporting cleaning verification/validation and the execution of the cleaning verification and validation programs.
- Manage and perform data analysis and lead/support investigations as required and support the team to make informed decisions/recommendations around conclusions reached from data analysis, using appropriate methodologies as required.
- Responsible for authoring portions of regulatory submissions and defending the commissioning, design and qualification of GMP equipment to regulatory agency representatives during inspections.
- Work collaboratively to lead a safe and compliant culture.
- May be required to perform other duties as assigned.
If you are interested in exploring this or at least hearing more, please get in contact ASAP or for a confidential conversation.
Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice. By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.