Senior Process Engineer

EFOR; Sligo; On-site; EUR 90,000 - 130,000; Full time

Job summary

EFOR Group in Sligo, Ireland, is seeking a Senior Project Engineer specialized in aseptic filling to lead capital projects in a center of excellence for fill/finish. You will drive scope, design, commissioning, qualification, and handover to Operations, partnering with Quality, Validation, and Automation teams.

The role requires 7+ years in pharmaceutical/biologics manufacturing, hands-on aseptic processing experience, and strong project-management and stakeholder skills.

Qualifications

• Bachelor's or Master's in Engineering (Mechanical, Chemical, Biotech, or related discipline).
• 7+ years' experience in pharmaceutical/biologics manufacturing with project/process engineering roles.
• Proven track record delivering capital projects in sterile/aseptic environments (vial filling lines, isolators, lyophilizers).
• Knowledge of cGMP, Annex 1, FDA/EMA and validation lifecycle (URS, DQ, IQ, OQ, PQ, PPQ).
• Hands-on familiarity with aseptic processing technology (isolators/RABS, filling systems, lyophilization) and biologics handling.
• Project management skills: budget ownership, scheduling, vendor management, cross-functional leadership.
• Strong stakeholder management, communication, problem-solving; able to lead technical discussions.
• PMP or Lean/Six Sigma certification is advantageous.

Responsibilities

• Lead capital and process improvement projects from scope through commissioning and handover.
• Drive equipment introduction and tech transfer for isolator-based lines and lyophilizers.
• Own project engineering deliverables: URS, FAT/SAT, IOQ/PQ, risk assessments.
• Act as technical lead and single point of contact for cross-functional stakeholders.
• Manage contractors, vendors, and internal resources; track budgets and timelines.
• Support investigations and CAPA resolution for equipment/process deviations.
• Ensure work complies with cGMP, Annex 1, and site EHS requirements.

Skills

Project management

Stakeholder management

Communication

Problem-solving

Cross-functional leadership

cGMP knowledge

Education

Engineering degree (Bachelor's or Master's)

Job description

Now Hiring: Senior Project Engineer – Aseptic Filling (Sligo, Ireland | Onsite)

Are you a seasoned engineering leader with deep expertise in aseptic biologics manufacturing, ready to drive high-impact projects at a center of excellence for fill/finish? EFOR Group, a trusted Life Sciences consulting partner, is seeking an experienced Senior Project Engineer to join our team in Sligo.

What you'll do:

• Lead capital and process improvement projects across aseptic fill/finish operations, from scope and design through commissioning, qualification, and handover to Operations
• Drive equipment introduction and technology transfer for isolator-based filling lines, lyophilization systems, and associated automation, ensuring on-time, on-budget delivery
• Own project engineering deliverables including URS, FAT/SAT, IOQ/PQ protocols, and risk assessments, in close coordination with Quality, Validation, and Automation teams
• Act as technical lead and single point of contact for cross-functional stakeholders (Production, Quality, Engineering, Global S&T) throughout the project lifecycle
• Manage contractors, vendors, and internal resources, tracking project budgets, timelines, and risk registers
• Support investigation and resolution of complex equipment or process deviations tied to project scope, and drive CAPA implementation
• Ensure all project work aligns with cGMP, Annex 1, and site EHS requirements, particularly around isolator/RABS containment and aseptic process design

Your background:

• Bachelor's or Master's in Engineering (Mechanical, Chemical, Biotech, or related discipline)
• 7+ years' experience in pharmaceutical/biologics manufacturing, with significant exposure to project or process engineering roles
• Proven track record delivering capital projects in a sterile/aseptic environment — vial filling lines, isolators, lyophilizers, or similar
• Strong working knowledge of cGMP, Annex 1, FDA, EMA, and validation/qualification lifecycle (URS, DQ, IQ, OQ, PQ, PPQ)
• Hands-on familiarity with aseptic processing technology (isolators/RABS, peristaltic or piston filling systems, lyophilization) and biologics drug product handling
• Demonstrated project management skills — budget ownership, scheduling, vendor management, and cross-functional leadership
• Excellent stakeholder management, communication, and problem-solving skills, with the ability to lead technical discussions at all levels
• PMP or equivalent project management certification, and/or Lean/Six Sigma certification, is an advantage

Why EFOR Group?

EFOR unites over 3,200 experts in 18 countries, delivering unparalleled technical, quality, and engineering excellence across the full Life Sciences product lifecycle. Join a high-performing team committed to healthcare innovation, safety, and reliability.

Location: Sligo, Ireland (onsite)

Ready to lead the next generation of biologics manufacturing projects?

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