Senior Process Engineer

Morgan McKinley; Ireland; On-site; EUR 90,000 - 130,000; Full time

Job summary

Morgan McKinley is seeking a Senior Specialist, Process Engineering for its Dublin biopharmaceutical facility. You will champion upstream and downstream manufacturing design, qualification, and tech transfer to commercial readiness, while leading cross‑functional teams to improve yield and robustness.

You will also author regulatory submissions, manage analytics, and support audits in a high‑performing environment, leveraging Lean Six Sigma and PAT tools to drive continuous improvement.

Qualifications

• 7+ years in biopharmaceutical/biotechnology process engineering or related field.
• Experience with cGMP and global regulatory requirements.
• Strong DOE, MVDA, PAT and statistical analysis skills.
• Experience leading cross-functional teams and driving technical decisions.
• Ability to author regulatory filings and CTD sections.

Responsibilities

• Drive design, qualification, and commissioning of upstream and downstream equipment through tech transfer to commercial readiness.
• Oversee process monitoring, deviation investigations, and change controls to optimize yield and robustness.
• Direct DOE studies, laboratory-scale experiments, data modeling, and statistics to troubleshoot operations.
• Author and review master batch records, technical/campaign reports, and CTD sections for regulatory submissions.
• Lead continuous improvement using Lean Six Sigma tools and mentor MS&T teams.
• Act as SME during audits and regulatory inspections (FDA, HPRA/EMA).

Skills

Process engineering

cGMP

Regulatory submissions

DOE

MVDA

Statistical analysis

Leadership

Cross-functional collaboration

Education

Bachelor's degree in Chemical/Biochemical/Biology related field

Master's degree

PhD in process science or related field

Tools

JMP

Design-Expert

Process Analytical Technology (PAT)

MVDA software

Job description

A premier global biopharmaceutical organization is seeking an accomplished Senior Specialist, Process Engineering to join its state-of-the-art biologics facility in Dublin. In this pivotal technical role, you will champion the design, qualification, technology transfer, and commercial lifecycle management of upstream and downstream manufacturing processes.

Serving as a subject matter expert within MS&T, you will partner cross-functionally to drive technical investigations, advance yield and process robustness, author regulatory filings, and support regulatory audits in a high-performing commercial environment.

Key Responsibilities

• Facility & Process Delivery: Drive design, qualification, and commissioning of upstream and downstream equipment through tech transfer to commercial readiness.
• Commercial Process Science: Oversee proactive process monitoring (CPV, SPC, MVDA), identify trend shifts, lead complex deviation investigations, and execute data-driven change controls to optimize yield and robustness.
• Experimental Design & Optimization: Direct DOE, laboratory-scale studies, data modeling, and statistical analysis to troubleshoot operations and streamline routine manufacturing.
• Technical & Regulatory Documentation: Author and review master batch records, technical/campaign reports, FMEA risk assessments, and CTD sections for global regulatory submissions.
• Continuous Improvement: Utilize Lean Six Sigma tools to drive root-cause analysis, reduce process variability, and lead MS&T organizational initiatives.
• Audit & Inspection Readiness: Act as a key technical SME during internal audits and health authority regulatory inspections (e.g., FDA, HPRA/EMA).

Candidate Profile

• Education: Bachelor's, Master's, or PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, Biological Sciences, Chemistry, or a related discipline.
• Experience Requirements:
• BSc: 7+ years of relevant industry experience in biopharmaceutical/biotechnology manufacturing science or process engineering.
• MSc: 5+ years of directly applicable bioprocess experience.
• PhD: Strong academic research/development background in process science or relevant post-doctoral experience.
• Technical Mastery: Solid foundation in cGMP, global regulatory requirements, and technical operations for commercial drug substance manufacturing (cell culture or purification).
• Statistical Tools: Proficiency in statistical methodologies, DOE software (JMP, Design-Expert), multivariate data analysis (MVDA), or Process Analytical Technology (PAT).
• Leadership & Collaboration: Proven capability to lead multi-disciplinary teams, hold stakeholders accountable to project milestones, and translate complex process science into clear, actionable decisions.

Desirable Experience

• Direct hands‑on background in commercial-scale biologics drug substance operations (upstream cell culture or downstream purification).
• End-to-end exposure to Process Performance Qualification (PPQ), process characterization, and site‑readiness programs.
• Demonstrated track record managing contract manufacturing organizations (CDMOs) or authoring Module 3 regulatory submissions.