Orion Group are sourcing a Validation Engineer on behalf of our Multinational Biopharmaceutical Client on an initial 11-month contract located in Cork with huge potential to extend.
The Contractor will provide validation (utilities PQ, equipment PQ, cleaning validation) and technical support to the Vaccines IPT team. The role will be reporting to the Vaccines IPT Associate Director.
What you will do:
Execute cycle development, cleaning validation and PQ of equipment.
Writing and adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
Provide support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards.
Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
Technical report writing, statistical analysis of data
Adherence to the latest regulatory guidelines.
Represent the IPT on cross-functional project teams.
Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
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 Chemical Engineering, Biochemistry, Microbiology, Chemistry 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.
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.
