| Location | Dublin, - None Specified - |
|---|---|
| Business Sector | Biotechnology |
| Contact email | |
| Job ref | 26503 |
| Published | about 24 hours ago |
Join our Site Engineering Services department within the Small Molecule business unit of a leading pharmaceutical manufacturer as a CQV Engineer. You will be a key member of the team supporting a robust pipeline of current and future CAPEX projects, ranging from Oral Solid Dose (OSD) process equipment to facility utilities and automated computerized systems.
In this role, you will lead the commissioning and qualification lifecycle to ensure all equipment, facilities, and processes meet stringent cGMP standards. Your focus will be on delivering high-quality technical documentation, managing vendor transitions, and fostering a culture of quality and data integrity across the site’s engineering projects.
Education: Bachelor’s degree in Engineering, Science, or a related technical field (Engineering degree strongly preferred).
Minimum years of experience: Minimum of 5 years of related experience in a pharmaceutical manufacturing environment, validation, or engineering.
Core technical expertise: Proven experience in validation disciplines including OSD process/packaging equipment, facilities, utilities, and computerized systems.
Required hands-on skills: Expertise in technical writing for GMP documentation, including Change Controls, Risk Assessments, VMPs, URSs, DQ/FAT/SAT, and IOQs.
Required scientific/technical knowledge: In-depth knowledge of FDA cGMP regulations, validation methodologies, and risk-based qualification approaches.
Additional experience: Previous experience managing large-scale CAPEX projects and New Product Introductions (NPI) in a drug product environment.
Advanced technical skills: Proficiency in cleaning validation and the ability to resolve complex commissioning punch lists and validation deviations.
Specific technologies or platforms: Hands-on experience with Electronic Documentation Management Systems such as KNEAT, VEEVA, or TRACKWISE.
Industry or domain exposure: Experience with high-speed capsule filling and Uhlmann blister line equipment.
Soft skills or certifications: Strong project planning skills, strategic thinking, and the ability to influence stakeholders across Engineering, Quality, and EHS.
Start Date: 1st March 2025
Contract Duration: 12 Months
Location: Close to Dublin
Additional: This role requires a self-motivated individual capable of managing validation schedules and timelines with high accuracy and autonomy. It is essential that the candidate demonstrates end-to-end ownership of validation packages and possesses significant experience in technical documentation writing.
Interviews and offers can move quickly. Send your CV to Oluali Titelman at o.titelman@panda-int.com or call +31 (0)20 2044 502 today to secure your spot in the process.