Process Engineer

Desired Skills: process engineering,Lean Six Sigma,Change Management,kaizen,Formulation,Product Transfer

Note: this is a fully onsite role in Dundalk, Co. Louth – candidates should only apply if they’re satisfied with this arrangement

RESPONSIBILITIES:

• Provide technical leadership within a new Vaccine Drug Product Manufacturing facility.
• Ensure all equipment installed is safe, effective and in compliance with industry standards.
• Ensure all company and site engineering policies and procedures are adhered to.
• Provide technical and compliance review and/or authorship of testing protocols, reports and applicable manufacturing SOPs.
• Generate and execute documentation for cGMP activities including risk assessments /reports.
• Management of Equipment Vendors including execution of on-site maintenance visits, management of continuous improvement projects & spare parts criticality assessments.
• Support/lead maintenance of the validated state of the equipment through execution of revalidation protocols as per Site VMP.
• Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
• Manage changes to equipment/process as per site change control procedures.
• Support establishment of new Preventative Maintenance Program for equipment in Drug Product suite.
• Lead/participate in equipment related manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis & impact analysis is completed and appropriate CAPAs are implemented.
• Identify process and equipment improvements and develop these into CI projects.
• Support disposition of batches by addressing any potential technical / engineering related issues which may have occurred mid-batch.
• Lead/participate in, TPM, CI & Gemba programs and daily / weekly tiered manufacturing meetings.
• Provide technical expertise during regulatory inspections e.g. FDA, HPRA inspections to defend systems, change controls, investigations and qualification packages.
• Support transition from project to sustaining manufacturing and ramp up of production volumes in future by improving equipment reliability through CI and TPM processes.

REQUIREMENTS:

• Minimum 5 years cGMP industrial / engineering experience,
• Experience in executing on the floor activities such as FAT, SAT, IQ/OQ
• Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g. Six Sigma
• Experience in leading & resolving complex technical investigations.
• Experience in a risk-based approach to manufacturing through use of tools such as FMEA
• Ability to adapt to changing priorities as project demands change.

EDUCATION:

• Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.

OTHER SKILLS, ABILITIES & EXPERIENCE:

• Specific experience with Autoclave, Parts Washers, and CIP/SIP equipment.
• Knowledge of Formulation processes.
• Experience in start-up facilities is advantageous.
• CQV experience is advantageous.
• Knowledge of industry/ regulatory requirements such as Annex 1 desirable.
• Ability to explain complex technical issues to external customers / agencies.
• Demonstrated excellence in planning and organizational skills.
• Demonstrated skills in communication (oral and written) & in particular technical writing.

Please click the link below to apply or alternatively send an up-to-date CV to howie.leahy@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***