Validation Engineer III

Validation Engineer (Senior) – 12 month & 6 month contracts

Onsite position (Western Ireland) – Potential to WFH on ad-hoc basis at discretion of manager.

Joining team of approx. 6, reporting to Validation Team Leader.

Overview:

• Coordinate the development & maintenance of validation programs in compliance with applicable regulatory and company requirements.
• Help direct, implement and actively participate in the execution of the site Validation Program.

Responsibilities:

• Ensure computerized systems are all qualified in compliance with Data Integrity policies and regulatory requirements.
• Give direction and participate in the validation of site facilities / equipment / utilities / processes / software in compliance with company, FDA, European cGMP and GAMP standards.
• Generate & maintain Validation Master Plans.
• Generate & maintain Project Validation Plans.
• Ensure all validation plans, protocols and final reports are produced to cGMP standard.
• Review & approval protocols and final reports.
• Manage of validation change control process.
• Adhere to and support EHS & E standards, procedures and policies.

Work environment:

• Given authority to carry out you duties without close supervision, reporting to the Validation Team Leader.
• Goals are reviewed on a regular basis and formal performance reviews are carried out once per year.
• No direct reports, but will provide guidance to cross-functionally on Validation.
• May provide training and guidance to new department members.
• Close contact with employees within the plant at all levels.
• Close contact with internal and external auditors, e.g. FDA, HPRA.
• May lead and chair Cross Functional Team meetings.
• Expected to provide functional expertise to support daily operations.
• Seeks Managers input when making decisions which affect the area.
• Site SME on validation issues and provides guidance on same.
• Decision making within confines of agreed responsibility with Team Leader.

Qualifications / Attributes:

• Degree-level qualification in a relevant engineering/scientific discipline
• 5-10 years’ experience in a cGMP regulated environment is expected as minimum.
• Strong understanding of regulatory requirements.
• High level of attention to detail, to ensure accuracy and compliance with procedures at all times.
• Strong problem-solving skills and the ability to adapt to new regulatory requirements.
• Results driven, motivated to meet all targets and metric standards as set by site/department and division leaders.
• Commitment to quality and maintaining a high standard of work at all times.
• The highest levels of integrity and a strong work ethic.
• Excellent communication skills. both written and verbal.

Accountability:

• The position holds a high level of autonomy and an expectation to work on your own initiative.
• Procedures, policies and guidelines must be followed to ensure compliance with cGMP and HPRA/FDA regulations.
• Full responsibility for the co-ordination and closure of projects assigned.
• This position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned and resolved.
• Requires an ethos of Right First Time at all times.