Arcadis DPS Engineering are seeking a Process Engineer – Drug Product, to carry out a pharmaceutical assignment located in Dundalk.
This is an 11- month contract initially.
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 optimisation 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
Bachelor of Engineering or Science Degree in Engineering or Technology related discipline
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
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
Why Join Arcadis?
At Arcadis, we empower individuals to excel because your contributions matter.
Taking a skills-based approach, we provide opportunities for you to shape your career, maximize your impact, and grow professionally.
By joining us, you'll engage in meaningful work that drives sustainable solutions for a better planet while leaving a lasting legacy.
Our Commitment to Equality, Diversity, and Inclusion We are dedicated to creating an environment where everyone can thrive.
Through our six ED&I workstreams—Age, Disability, Faith, Gender, LGBT+, and Race— we foster innovation by bringing together diverse perspectives.
Together, we strive to improve quality of life while building a more inclusive future.
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