CQV Engineer

2 days ago

Dublin, Ireland PE Global Full time

The role: PE Global is currently recruiting for a CQV Engineer on behalf of a leading pharmaceutical company based in Dublin. This is an initial 12-month contract role. Overview: The CQV Engineer will be responsible for the commissioning, qualification, and validation of equipment, systems, and processes used in the production of drug substances. This role ensures that all systems operate as intended and comply with regulatory standards. The CQV Engineer will work closely with cross-functional teams, including engineering, quality assurance, and manufacturing, to support the successful delivery of projects. Responsibilities: Commissioning: Develop and execute commissioning plans for new and existing equipment and systems. Perform equipment start-up and troubleshooting to ensure proper operation. Document commissioning activities and results. Qualification: Develop and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, and systems. Ensure that all qualification activities comply with regulatory requirements and industry standards. Analyze qualification data and prepare comprehensive reports. Validation: Develop and execute validation protocols for processes and computer systems. Conduct risk assessments and gap analyses to identify critical process parameters and control strategies. Ensure validation activities are aligned with current Good Manufacturing Practices (cGMP) and regulatory guidelines. Documentation: Prepare and maintain detailed documentation, including protocols, reports, and standard operating procedures (SOPs). Ensure all documentation is accurate, complete, and compliant with regulatory requirements. Project Management: Manage multiple CQV projects simultaneously, ensuring timely completion and adherence to project timelines. Coordinate with cross-functional teams to ensure seamless project execution. Provide regular project updates and status reports to stakeholders. Compliance and Quality Assurance: Ensure all CQV activities comply with relevant regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ISPE, ASTM). Participate in internal and external audits and inspections. Implement corrective and preventive actions (CAPAs) as needed. Education and Experience: Bachelors degree in Engineering, Life Sciences, or a related field. Advanced degree preferred. Experience in CQV within the pharmaceutical or biotechnology industry, specifically in drug substance manufacturing. Experience with commissioning, qualification, and validation of biopharmaceutical equipment and systems (e.g., bioreactors, chromatography systems, filtration systems). Strong understanding of cGMP, FDA, EMA, and other relevant regulatory requirements. Proficiency in developing and executing IQ/OQ/PQ protocols. Familiarity with risk-based approaches to validation (e.g., ASTM E2500). Experience with process validation and computer system validation. Excellent problem-solving and analytical skills. Strong project management and organizational skills. Effective communication and interpersonal skills. Preferred Qualifications: Certification in Project Management (PMP) or CQV-related certifications. Experience with electronic documentation systems and validation lifecycle management software. Knowledge of Lean Six Sigma methodologies. Interested candidates should submit an updated CV. Please click the link below to apply, call Kellie on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: commissioning qualification validation project management

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