Commissoning and Qualiification lead

4 weeks ago


Dublin, Ireland Pharmiweb Full time

Commissioning and Qualification (C&Q) Lead for a large scale Fill Finish Project in the Pharmaceutical Industry.

Lead a team of C&Q engineers to ensure the C&Q activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.

Key Responsibilities:

* Coordinates and Supervises all C&Q activities
* Approves C&Q planning documents detailing overall strategy for the project.
* Develops and approves the master list of C&Q test documents and activities.
* Reviews and Approves all C&Q summary reports.
* Ensures the C&Q schedule is developed and maintained.
* Ensures all C&Q Engineers who perform C&Q activities have relevant training assigned.
* Pre-Approval and Post approval of C&Q test documents.
* Manages Daily C&Q coordination meetings.
* Responsible for Overall Tracking and Reporting of C&Q status and risks/issues.
* Ensures Startup of equipment/utilities is completed in a safe and coordinated manner.
* Management and tracking of turnover process data base, including Walkdowns, Turnover Packages, Mechanical Completion, Final Completion.
* Day to day liaison with the Construction Management Team
* Generation of the Turnover and Care, Custody Control strategy and plan for the project (including use of project databases)
* Management, collation and presentation of Right First Time data for protocol and turnover package review
* Writing of test protocols when required
* Compilation and Presentation of weekly progress summaries for project
* Review and approval of vendor equipment turn over packs and test documentation.
* Use of the Risk-based ASTM E2500 standards and approach to Qualification
* Liaise with C&Q Engineers and Lead Scheduler in relation to schedule creation and management for all Process Equipment Support, ensuring all correct predecessors and successors are in place
* Ensure Commissioning readiness of all Systems to support Equipment Start-up and C&Q Testing
* Liaise with all Project Groups (Design/CM/C&Q/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure Systems are managed appropriately for the entire Project Lifecycle

Qualifications & Requirements

* Minimum 10 years C&Q experience
* Working knowledge of ASTM E2500 / Leveraging Verification process
* Minimum of 10 years experience with design and construction projects for biopharmaceutical manufacturing facilities 
* Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Office / Project)


  • Scheduler Lead

    1 month ago


    Dublin, Ireland John Sisk and Son Full time

    Founded in 1859, we are an International Construction Company that strongly emphasises performance, quality, teamwork and a "hands-on” management approach to ensure client satisfaction. Family ownership for five generations has set the cultural tone for John Sisk & Son. We have been Building Excellence for over 150 years by building trust, certainty and...


  • Dublin, Dublin City, Ireland eli lilly and company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • MEP Lead

    1 month ago


    Dublin, Ireland John Sisk and Son Full time

    Founded in 1859, we are an International Construction Company that strongly emphasises performance, quality, teamwork and a "hands-on” management approach to ensure client satisfaction. Family ownership for five generations has set the cultural tone for John Sisk & Son. We have been Building Excellence for over 150 years by building trust, certainty, and...


  • Dublin, Ireland John Sisk and Son Full time

    Senior Planner - Dublin, Ireland To lead the planning management function for the Sisk group of companies. To set the standard for planning and project controls and regularly review the function in the preconstruction and construction phases. To develop a consistent approach and produce regular reports to feedback on progress and performance to...

  • Deputy Manager

    1 month ago


    Dublin, Ireland Holland and Barrett Full time

    Are you passionate about customer service? Keen to continue your career with the largest UK Health and Wellness Retailer? As a Deputy Retail Manager, you'll be second in command supporting the day-to-day management of the store and become a brand ambassador for Holland & Barrett.  You'll partner with the Store Manager to build a high performing team...

  • Deputy Manager

    6 days ago


    Dublin, Ireland Holland and Barrett Full time

    Are you passionate about customer service? Keen to continue your career with the largest UK Health and Wellness Retailer? As a Deputy Retail Manager, you'll be second in command supporting the day-to-day management of the store and become a brand ambassador for Holland & Barrett.  You'll partner with the Store Manager to build a high performing team...


  • Dublin, Ireland GKR Search and Selection Full time

    Our client, a high-profile global aircraft leasing corporation, is recruiting for an Insurance Manager to direct a diverse range of insurance-related operations. Responsibilities: Deliver strategic insurance insights, guidance, and reporting across multiple business divisions. Ensure strict compliance with lease agreements. Manage and liaise with...


  • Dublin, Ireland John Sisk and Son Full time

    Founded in 1859, we are an International Construction Company that strongly emphasises performance, quality, teamwork and a "hands-on” management approach to ensure client satisfaction. Family ownership for five generations has set the cultural tone for John Sisk & Son. We have been Building Excellence for over 150 years by building trust, certainty, and...


  • Dublin, Dublin City, Ireland GKR Search and Selection Full time

    Aircraft Leasing VP Credit and Strategy *Remote working available About the job Our client, a global aircraft leasing company, is currently experiencing growth and has an exciting opportunity for Aircraft Leasing VP Credit and Strategy to join the team. Responsibilities: Credit and pricing analysis assessing structured asset finance transactions for...


  • Dublin, Ireland John Sisk and Son Full time

    #IJ Founded in 1859, we are an International Construction Company that strongly emphasises performance, quality, teamwork and a "hands-on” management approach to ensure client satisfaction. Family ownership for five generations has set the cultural tone for John Sisk & Son. We have been Building Excellence for over 150 years by building trust, certainty,...


  • Dublin, Ireland GKR Search and Selection Full time

    We are recruiting for three aircraft lessors based in Dublin who are recruiting for a VP and SVP Legal. These are excellent opportunities with well-established lessors. Responsibilities : Manage cross-border aircraft leasing transactions Manage aircraft acquisitions and sales, aircraft operating leases, and associated finance transactions. Manage...

  • Warehouse Operative

    1 month ago


    Dublin, Ireland Truck and Bus Parts Full time

    Truck and Bus Parts are Ireland's leading parts supplier to the HGV aftermarket sector. We are looking for a Warehouse Operative to join our gowing team. This role will suit anyone with a knowledge/interest in the truck, bus, trailer or vans parts sector. Duties will include but not limited to: Receiving in and checkning goods from suppliers and put...

  • Associate Director

    6 days ago


    Dublin, Dublin City, Ireland eli lilly and company Full time

    Associate Director - Clinical Trial Patient Engagement page is loaded Associate Director - Clinical Trial Patient Engagement Apply locations Ireland, Cork time type Full time posted on Posted 22 Days Ago job requisition id R-61929 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader...

  • Finance Manager

    2 days ago


    Dublin, Ireland GKR Search and Selection Full time

    Join our client, a prominent entity in the aviation leasing industry, as a Finance Manager. This role at an established aircraft leasing consultancy requires a candidate who thrives in a dynamic environment, bringing a strong analytical mindset and precise attention to detail. Key Responsibilities: Financial Oversight: Prepare and analyse monthly...

  • 4D Engineer

    4 weeks ago


    Dublin, Ireland John Sisk and Son Full time

    Founded in 1859, John Sisk & Son is in its fifth generation of family ownership. The Sisk Values are woven into everything we do – Care, Excellence, and Integrity. Our Vision is to dedicate ourselves to Building Excellence, delivering projects of constantly high quality which exceed our clients’ expectations. Our people are at the heart of our success....


  • Dublin, Ireland GKR Search and Selection Full time

    Aircraft Leasing AVP Legal (Legal Counsel) We have been retained by a major aircraft leasing firm which is recruiting for an AVP Legal. This is an exciting opportunity to step into the role of AVP Transaction Legal, based in Dublin. This role offers a chance to be at the forefront of negotiating and documenting high-value contracts within the aircraft...


  • Dublin, Ireland GKR Search and Selection Full time

    Aircraft Leasing Legal Counsel We have been retained by a major aircraft leasing firm which is recruiting for a Legal Counsel. This is an exciting opportunity to step into the role of a Transaction Counsel, based in Dublin. This role offers a chance to be at the forefront of negotiating and documenting high-value contracts within the aircraft leasing...


  • Dublin, Ireland GKR Search and Selection Full time

    Aviation Finance VP Risk About the job Our client, a global aviation finance company, is experiencing significant growth and has an exciting opportunity for a credit risk professional to take ownership of the risk function. Responsibilities: Develop the risk management and credit underwriting processes. Analysing transactions for airline and...

  • Associate Director

    1 day ago


    Dublin, Dublin City, Ireland eli lilly and company Full time

    Associate Director - Clinical Central Services and InnovationAt Lilly, we strive to bring impactful medicines and solutions to individuals worldwide. Join our team based in Indianapolis, Indiana to contribute to our mission of enhancing healthcare and giving back to communities through philanthropy and volunteerism. We are seeking dedicated individuals who...

  • Senior Engineer

    4 weeks ago


    Dublin, Ireland John Sisk and Son Full time

    Sisk, founded in 1859, we are an International Construction Company that strongly emphasises performance, quality, teamwork and a "hands-on” management approach to ensure client satisfaction. Family ownership for five generations has set the cultural tone for John Sisk & Son. We have been Building Excellence for over 150 years by building trust, certainty...