QA Validation Engineer

Excellent opportunity for a QA Validation Engineer to join a global Biologics Leader in Ireland . The ideal person will have a strong pharma / biopharma background with experience in commissioning and qualification of manufacturing process equipment , analytical and benchtop systems, facilities, utilities and GxP systems.

Overview of your responsibilities (full job description available on request):

• The QA Validation Engineer will provide technical support to QA Engineers and Computerised System Quality Specialists

• The QA Validation Engineer will support team schedule management to ensure project needs are met

• Quality review and approval of qualification/validation documentation and associated data in the following areas:

• facilities, utilities, equipment, computerised systems, cleaning, process, storage areas, controlled temperature units (CTUs) and shipping data

• Ensure compliance with cGMP, industry standards and regulatory requirements.

• Quality review and approval of Standard Operating Procedures (SOPs).

• Preparation of SOPs relating to QA Validation Activities

Knowledge, Skills and Experience Required for the Role:

• A third level degree in a scientific/technical discipline (e.g. biochemistry, chemistry, engineering,) ideal

• Demonstrated experience in commissioning and qualification of manufacturing process equipment , analytical and benchtop systems, facilities, utilities and GxP systems.

• Demonstrated knowledge / experience of c leaning validation , product process validation and shipping validation either as CQV / CSV engineer or as quality reviewer / approver.

• Capability to manage your own schedule, representing dept a key meetings, decision making and problem solving.

• Previous experience in a quality engineering / QA role with robust understanding of GxP regulations would be ideal

• Experience in change control and deviation management would be ideal.

For a confidential discussion and more information on the role contact Courtney Russell