Validation Specialist

Orion Group Life Sciences are currently recruiting a Validation Specialist on behalf of our Multinational Biopharmaceutical client based in Cork on an initial 11-month contract with huge potential to extend.

The individual will provide validation and technical support to the Vaccines IPT team and the role will be reporting to the Vaccines IPT Associate Director.

What you will do:

• Execute and provide technical support for Building 8 upgrade project during the C&Q phase.
• Execute the validation of equipment, cleaning, utility systems, facilities, processes and/or automation systems for projects and post OQ activities. This includes adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
• Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
• Technical report writing, statistical analysis of data
• Support the completion of validation projects through adhering to validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing
• Adherence to the latest regulatory guidelines.
• Apply Lean Six Sigma and Lean methodologies to drive a culture of Continuous Improvement within the IPT.
• Represent the IPT on cross-functional project teams.
• Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
• Assess and align Technical IPT priorities to the IPT and in turn site strategic map.
• Adherence to highest standards for Compliance (Quality and Safety)
• Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.
• Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

What skills you will need:

• 3-5 years' experience as a validation specialist in a pharmaceutical or a highly regulated environment and a B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering or a related field.
• Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
• A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS and eVAL, electronic batch records.

For more information on this role, call Beatriz Olmedo on +353 21 235 2900 or email beatriz.olmedo@orioneng.com for a completely confidential chat about this role and other opportunities.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.