Process Engineer
Department: Technical Operations
Reports to: NPI Technical Manager
Duration:
12-month contract
Location:
Sligo - 100% onsite
Team:
Tech Ops (approx. 10 people) Split into
Process (equipment)
and
Product (NPI)
teams
Primary Focus:
Support installation of a new fill-finish line
Key Role:
Act as SME for new processes. Collaborate with cross-functional teams (Quality, Ops, Sterility, etc.) for operational readiness
Required Skills:
Report writing &Protocol development
Desirable:
Six Sigma (not essential)
Experience:
* 3 years in Biologics (fill finish or drug substance)
* API experience may be considered but not preferred
Top Skills Needed:
* DP fill-finish experience for Biologics
* Experience with LYO products
* Experience with technical transfer projects (gap assessment, cleaning assessment, etc.)
* Familiarity with single-use system DP processes
Responsibilities
Core Responsibilities
* Conduct gap analyses, facility fit studies, process safety, and risk assessments for NPI.
* Monitor and analyse process data during manufacturing.
* Support development of manufacturing processes for new products.
* Provide operational technical support for resolving process issues.
* Prepare and update specifications for NPI materials and consumables.
* Lead or assist in risk assessments (PFMEA, EHS).
* Develop NPI documentation:
* Transfer Plans
* Protocols
* Procedures
* Manufacturing Batch Records
* Collaborate with global science and quality teams on future product development.
* Lead or assist in investigations and change plans (product/process).
* Support, supervise, and train operations personnel on NPI processes.
* Ensure adherence to all EHS&E standards, policies, and procedures.
Requirements
Essential
* Third-level degree in engineering, science, or technical discipline.
Desired
* Master's degree in a relevant technical field.
* 3 years' experience in pharmaceutical process engineering, including:
* Batch processing
* Technical transfers
* Scale-up
* cGMP environment
* Biologics industry experience desirable
* Experience introducing new products to Biologic facilities.
Technical / Business Knowledge
* Minimum 1 year in a similar role.
* Minimum 1 year in Pharmaceutical or Biologics industry.
* Strong technical and operational knowledge of unit operations in a fill-finish facility.
Cognitive Skills
* Strong problem-solving skills under pressure.
* Ability to evaluate multiple viable solutions per problem.
* Innovative thinker; able to propose and implement new solutions.
* High attention to detail and accuracy.
* Results-driven; meets targets and metrics.
* Strong commitment to quality and compliance.
* High integrity and strong work ethic.
* Strong verbal and written communication skills.
* Strong interpersonal skills.
* Understands and supports Perfect Performance principles.
* Ability to prioritise own and team workload.
Ownership / Accountability
* Aligns with AbbVie Vision, Strategic Imperatives, Operational Pillars, and Ways of Work.
* Works autonomously; strong self-initiative.
* Supports execution of commercial product campaigns and NPIs.
* Partners with EHS&E on safety tasks.
* Demonstrates tenacity for issue closure.
* Promotes Right First Time culture.
* Ensures compliance with cGMP, HPRA/FDA regulations, and company policies.
Influence / Leadership
* Supports and may lead cross-functional teams and cost-improvement projects.
* Builds strong relationships with MS&T and GPRD.
* Provides technical leadership to functional areas.
* Leads sub-projects related to commercial or NPI activities.
* Influences leaders on system improvement projects.
* Contributes to site CJRs, goals, and new Tech Ops initiatives.
* Selects, motivates, and trains staff; supports Talent Management.
Decision Making / Impact
* Provides functional expertise to daily operations.
* Seeks Manager input for significant decisions affecting the area.
Supervision
* Received:
Operates mostly self-managed; reports to NPI Technical Manager.
* Provided:
May supervise ODP, TDP, or interns as needed.
EHS Responsibilities
* Comply with EHS policies and procedures.
* Maintain personal and team safety awareness.
* Report incidents or near-misses immediately.
* Promote EHS improvement opportunities.
* Attend required training and medical surveillance.
* Wear PPE as required.