Biotech Commissioning

Biotech Commissioning & Qualification Lead - Dun Laoghaire, Dublin

Office/Project Location:Dun Laoghaire, Dublin

Employment Type: Contract

Work Location: Hybrid

Pay: €80 - 90 per hour

Experience: 10+ years

Visa: EU passport or Stamp 4 visa required

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin. 

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. 

This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

We are seeking a highly experienced C&Q [AREA] Lead to manage and oversee commissioning and qualification activities for the [AREA] scope of a new drug product manufacturing facility. 

This role is crucial in ensuring that systems, equipment, and facilities comply with cGMP standards and regulatory requirements, and are fit for their intended use.

Lead the planning, execution, and documentation of C&Q activities for the designated [AREA], including equipment, utilities, facilities, and processes.

Develop and maintain area-specific C&Q plans, test strategies, and supporting documentation.

Collaborate with cross-functional teams (Engineering, Operations, Quality, Contractors) to ensure timely and compliant execution of C&Q deliverables.

Provide subject matter expertise on pharmaceutical standards (e.g., GAMP, ISPE, ICH) and regulatory expectations (e.g., FDA, EMA).

Review, approve, and ensure completeness of C&Q documentation, including protocols, risk assessments, and summary reports.

Track and resolve discrepancies, deviations, and change controls related to C&Q activities.

Drive continuous improvement initiatives to enhance C&Q processes and reduce project risk.

C&Q Area Lead Filling / AVI:

Aseptic Filling Experience: Looking for candidates with 5 years' experience in filling lines and/or Automated Visual Inspection technology.

Risk Management Skills: Ability to coordinate and manage execution teams, prioritize schedule-driven tasks, escalate issues timely, especially those affecting other areas or having cost implications.

C&Q Area Lead Component Preparation & Formulation:

Expertise Needed: Familiarity with single-use technologies like SUMs, Partwashers, and Autoclaves is essential.

Quality Compliance: Candidates should execute tasks with a "right-first-time" approach.

C&Q Area Lead HVAC / Cleanrooms:

HVAC Validation Skills: Candidates should have experience working with construction handovers and cleanroom qualifications, alongside coordinating Test & Balance teams.

Environmental Monitoring: Experience in vendor management and familiarity with Building Management Systems (BMS) and Non-Qualified Building Management Systems (NQBMS).

C&Q Area Lead Utilities (Clean & Grey):

Utilities Qualification: Requires 5+ years of senior-level experience in clean and grey utilities qualifications.

Efficiency Strategies: Candidates should understand fast-track projects, sub-system needs, and commissioning efforts.

C&Q Area Lead & Warehouse Laboratory:

Integration Skills: Candidates should have knowledge of analytical instrument qualification and temperature mapping experience to ensure seamless integration of warehouse operations with lab qualifications.

Requirements

Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.

5–10+ years of experience in Commissioning & Qualification within a GMP-regulated environment, preferably in the pharmaceutical or biopharmaceutical sector.

Proven leadership experience managing C&Q teams or specific project areas.

Candidates should have a practical mindset and be self-starters. 

Essential traits include strong communication abilities, experience with large-scale project delivery, and proficiency in digital documentation tools.

Problem-Solving Skills: Ability to engage with vendors and effectively communicate resolutions to issues.

Team Collaboration: Excellent communication skills are crucial for managing cross-functional teams during C&Q activities.

Continuous Improvement: Self-starting individuals who can adhere to schedules and drive improvements are ideal.

Strong technical knowledge of commissioning, qualification, and validation practices.

Deep understanding of regulatory guidelines and industry best practices (FDA, EMA, ICH, ISPE, GAMP).

Experience with digital validation tools (e.g., Kneat, EDMS).

Excellent communication, leadership, and interpersonal skills.

Strong analytical and problem-solving abilities.

Ability to manage multiple priorities in a fast-paced, dynamic environment.

Package

Contract role - Hourly rate €80 - €90 per hour

Minimum 12 month contract with the possibility of an extension. 

Onsite expectations: Adaptable to a hybrid work model - able to work remotely but ready to be onsite quickly when needed. 

Please note the roles will transition into onsite roles.