Validation Manager - Laboratory equipment

Validation Manager

We are seeking an experienced Validation Manager to join our Client’s Ballina site in Co. Mayo, Ireland. Our client is a major player in the global life science sector and is expanding their facility in Co. Mayo. This is a permanent role and you will join a busy and progressive company.

You will be welcomed into a highly personable environment which is designed to enable professionals to make a major contribution to the development of pharmaceutical products and therapies.

The successful candidate will be rewarded with a highly competitive salary which will be accompanied with health insurance, pension contribution and life assurance. Furthermore, your new employer will provide extensive training and support.

* Note: Computer System Validation is outside the scope of this role.

The main duties & responsibilities of the Validation Manager are as follows:-

• Responsible for the coordination of all Validation activities at the Ballina site.

• Site Subject Matter Expert for the validation function

• Manage the Validations Team on a day-to-day basis, identify training requirements and develop the skillset within the group to support operations relating to validation.

• Develop individual goals and objectives for validation team members to support personal and company goals.

• Represent the Validations Department in regulatory (FDA/HPRA) and client audits as required.

• Ensure adherence to the site Validation Master Plan in all activities performed by the Validation Department.

• Accountable for writing, executing & reporting of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments/ PVP).

• Supporting the Validations team in completing any deviations/out of limits encountered during validation projects and implementing effective CAPA actions.

• Coordination of on-site Validation Contractor Activities to ensure adherence to EH&S and Quality systems requirements.

• To work closely with other Departments and the Quality Department to ensure the operation of a validated environment according to GMP and other regulatory requirements

• Technical review and approval of Validation documents submitted by the validations team or external vendors.

• Be a team member for Capital projects involving Validation deliverables identified by site management.

• Maintenance of key site Validation documents to include Validation Master Plan, Equipment and Process Validation Master Plan, Validation Department SOP’s, Site Re-Qualification Schedule.

• Ensuring that all site validation equipment (Data Loggers, Hot Blocks, Pressure Transducers etc) are regularly calibrated and certified for use.

• Coordinate and communicate the Validation schedule to site management on a regular basis.

The following are minimum requirements related to the Validation Manager position:

• Bachelor's degree in Science, Engineering, Technology or a related discipline

• Minimum of 3 years’ experience as a validation engineer/specialist in a cGMP environment preferably in another CRO or in the Medical Device/Pharma Industry.

• Proven track record of managing people

• Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.

• Good time management and planning skills

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Continuously drive to improve processes for improved performance

Pension

Life Assurance

Health Insurance