Cleaning Validation Engineer

A fantastic opportunity has arisen for a Validation Specialist at PSC Biotech's Drug Substance and Drug Product Facility in Co. Louth, Ireland. The successful candidate will take a lead on utilizing the latest innovations in technology, developing and maintaining the site Validation Master Plan, and driving the development of site cleaning strategy and protocols.

Requirements

• Support the site validation activities across a number of workstreams.
• Develop and maintain the site Validation Master Plan.
• Drive development of site cleaning strategy and implement/maintain cleaning and sanitisation protocols and procedures for pharmaceutical equipment, ensuring compliance with regulatory guidelines.
• Perform risk assessments to determine the criticality of cleaning processes and set acceptance criteria.
• Oversee cleaning validation studies, ensuring proper execution, data collection, and documentation.
• Collaborate with production and maintenance teams to establish cleaning procedures and cleaning validation requirements.
• Draft, review and approve cleaning validation documentation, reports, and deviation investigations.
• Conduct periodic reviews of cleaning validation programs to ensure their ongoing effectiveness.
• Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and subsequent revalidation.
• Support global regulatory submissions, internal audits and external inspections/audits as needed.
• Facilitate problem solving & risk assessment projects/meetings.
• Making problems visible and strive for continuous improvement.
• Lead and support various organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
• Keep up to date with scientific and technical developments.
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

Benefits

• Unparalleled empowering career development though Learning & Development in-house training mentorship
• Constant guidance to facilitate career progression
• Creating high performing teams that can exceed client's expectations
• Staying under budget and ensuring timelines for deliverables are met