SKILLS BRIEF:

Essential:

• At least 2 years validation experience in a regulated environment.
• Proven experience writing validation equipment SOP’s.
• Proven experience of setting up change controls.
• Excellent project management skills
• Strong critical thinking skills

Preferred:

• 1 years Pharma or Life Sciences manufacturing sector validation experience.

THE ROLE:

• Lab Validation Engineer
• 6 Month Fixed Term Contract
• Westport, Mayo
• Onsite role

ROLE BRIEF:

In this role you will be responsible for for the qualification / validation of laboratory equipment, systems and processes for an NNIT client. You also revalidate a range of mission critical systems. All validation activity will be be performed in line with GMP and FDA and other regulatory requirements. You will work with client management and business units to ensure all projects are delivered on time and budget.

Primary Responsibilities:

• Support equipment validation and potentially some CSV activities.
• Over-see, coordinate, guide and implement the site validation master plan under prospective, concurrent, and retrospective validation studies in a timely manner, with the relevant engineers. To ensure that all validation requirements are met for any new process, equipment or change to existing process or equipment.
• To actively work on validation projects, being the departmental point person and completing all associated project documentation in line with current corporate and regulatory expectations.
• Participate in risk assessment process for all business units & participate in design review process for all business units.
• Track and generate weekly metrics (GTW QMS, EHS, Compliance Wire etc.)
• To facilitate the PQR review process / Regulatory Review Process and Laboratory Equipment Review Process as required to meet project timelines.
• Provide support for audit preparation, direct audit interaction and involvement in audit response.
• Support and comply with internal EHS requirements, procedures and policies. Ensure continued conformance to the EMS within the department.