C&Q Leads – Dublin Contractor

We are hiring 5 C&Q Leads for different areas of the site.

Role-Specific Qualifications:

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.

Position Overview:

We are seeking a highly experienced C&Q Lead to manage and oversee commissioning and qualification activities for the cope 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.

Key Responsibilities:

• Lead the planning, execution, and documentation of C&Q activities for the designated 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.

Qualifications:

• 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.
• 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.