Validation Engineer

Desired Skills: cleaning validation,GMP,process validation

The role:

PE Global is currently recruiting for a Cleaning Validation Engineer on behalf of a leading pharmaceutical company based in Dublin North. This is an initial 12 month contract role.

Position Summary:

This role of Cleaning Validation Engineer will be responsible for cleaning validation activities relating to tech transfer of a new product introduction (NPI) to drug substance multi-product manufacturing facility. Cleaning validation is a process used to provide documented evidence that equipment and facilities are properly cleaned before being used to produce biopharmaceuticals. Contamination can be introduced by other product ingredients, cleaning agents, micro-organisms or by other materials (e.g. air-borne particles, dust, lubricants, raw materials, intermediates). The same equipment may be used for processing different products which may also lead to contamination, therefore adequate cleaning procedures are critical.

This position will report to the Senior Manager, CQV and will work across CQV workstreams with an initial focus on cleaning validation for NPI.

Responsibilities:

• Performing all aspects of cleaning sampling required for cleaning validation for a new product.
• Activities include swab and rinse sampling, sample preparation, LIMS administration, submission to QC for analysis, correlation of QC results with cleaning change over protocols/ cleaning logbooks.
• Supporting product changeover activities.
• Assisting with LOTO (lockout/ Tagout) activities where required.
• Generation of standardized cleaning validation ECPs (Energy Control Plans).
• Generation of cleaning validation documentation for new product introductions, process changes, audit observations and other required actions.
• Investigation support using QMS (Quality Management Systems) and troubleshooting for cleaning validation issues.
• Cleaning validation release memos to support product release.
• Oversight of the visual inspection qualification and requalification process on site.
• Adhering to project deadlines as scheduled by the project manager.
• Inputting to a wider projects team as CQV representative and liaising with cross-functional teams to ensure timely completion and approval of cleaning validation deliverables.
• Investigation support using QMS (Quality Management Systems) and troubleshooting for cleaning validation issues.
• Ensuring adherence to governing site and global procedures and regulatory guidelines.

Education & Experience:

• The candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline.
• Previous cleaning validation experience is an advantage.
• The ideal candidate would have biopharmaceutical Process / Validation knowledge.
• Exposure to cGMP in a fast-paced environment is required.
• Previous experience in working in a drug product filling facility would be advantageous.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***