Process & Cleaning Validation Specialist

CareerWise Recruitment; Dublin; Hybrid; EUR 52,000 - 72,000; Part time

Job summary

CareerWise Recruitment is seeking a Validation Specialist for a North-West Dublin based client on an 18-month agency contract. The role covers Process Validation/Qualification across production areas including Process, Cleaning, Software, Utility and Facility projects.

You will generate, execute and close out validation activities (FAT/IQ/OQ/PQ/FMEA). A Bachelor's degree and cGMP experience are required, with strong technical writing and ability to manage multiple priorities.

Qualifications

• Bachelor's Degree in Science, Engineering, Technology or a related discipline.
• Hands-on experience as a Process/ Cleaning Validation Engineer/Specialist in a cGMP environment, preferably in an Oral Solid Dose facility.
• Full understanding of cGMP requirements, including Annex 11 and Annex 15.
• Effective technical writing skills.
• Excellent interpersonal, leadership, communication and time-management skills.
• Flexible and able to manage multiple priorities simultaneously.

Responsibilities

• Process Validation/Qualification projects across production areas including Process, Cleaning, Software, Utility and Facility.
• Generation, execution and close out of validation projects for existing products and new product introductions.
• Writing, executing and reporting of all validation activities including FAT/IQ/OQ/PQ/FMEA.
• Participate in project teams and assist in determining project schedules and validation levels.
• Execute and document risk assessments (FMEA) with respect to validation activities.
• Perform validation functional testing and track/deal with deviations during qualification.

Skills

Process Validation

cGMP

Technical writing

Education

Bachelor's Degree in Science/Engineering/Technology

Job description

A Validation Specialist (18 Months Agency Contract) is required by CareerWise Recruitment for our North-West Dublin based client. Main duties/Skillsets include Process Validation/Qualification projects across a range of production areas which include Process, Cleaning, Software, Utility and Facility projects. 2-3 years experience required - 3 days per week on-site - flexible working hours.

THE ROLE:

• Process Validation/Qualification projects will be across a range of production areas which may include Process, Cleaning, Software, Utility and Facility projects.
• Generation, execution and close out of validation projects relating to existing products and new product introductions.
• Accountable for writing, executing & reporting of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments/ PVP).
• Participate in project teams and assist in determining project schedules and the appropriate levels of validation.
• Execution and documenting risk assessments (FMEA) with respect to validation activities.
• Perform validation functional testing as required. Track and resolve deviations during qualification activities.

REQUIREMENTS:

• Bachelor's Degree in Science, Engineering, Technology or a related discipline.
• Hands-on experience working as a Process/ Cleaning Validation Engineer/Specialist in a cGMP environment, preferably in an Oral Solid Dose facility.
• Full understanding of cGMP requirements, including Annex 11 and Annex 15.
• Effective technical writing skills.
• Excellent interpersonal, leadership, communication (written and verbal) and time-management skills.
• Flexible and able to manage multiple priorities simultaneously.