Primary purpose is to maintain the validated status of products and the plant through all aspects of validation- process, cleaning, equipment, facilities and computerised systems validation, which are outlined in the site validation master plan.
Responsibilities:
Co-ordinate the introduction of all processes, equipment and computerised systems.
Write and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements utilising scientific/technical knowledge.
Co-ordinate, prepare and execute cleaning verification and validation protocols and reports (site Subject Matter Expert).
Write and execute installation, operational and performance qualification protocols for the introductions of new equipment/systems/facilities and re-validations due to changes/improvements coming out of change control.
Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented.
Generation of risk assessments, covering cleaning, validation and process.
Mentoring of new employees within the Technical Services team.
Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
Acts in an advisory role to project engineers regarding potential cross contamination and cleaning issues in multi-product process trains.
Directly supports GMP and regulatory audits
Prepare and deliver training modules as required
Requirements:
Bachelor's degree in Science, engineering or technology required
3 years validation engineer/specialist in cGMP environment
DPS Engineering is an Equal Opportunities Employer.
Recruitment Agencies: Please do not reply to this job advert.
