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.

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.

For further information on this role please contact Geraldine Gormally on 0861071395  / recruit@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/  

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