- Location
- Wexford-Wexford, IE
- Department
- IT
- Seniority
- Manager
- Experience
- 8+ years
- Closing date
- Today
- Source
- iCIMS
Description
Overview
The Waters Advanced Diagnostics (ADx) Division provides globally recognized scientific and commercial leadership in clinical diagnostics, enabling laboratories to deliver high-quality, reliable results that improve patient care. Through workflow-based solutions, the ADx division advances the adoption of LC-MS as a routine diagnostic technology across global clinical markets.
The Technical Operations Manager is a new role created within the ADx LC-MS R&D organisation responsible for end-to-end process verification and validation, scale-up, and transfer of manufacturing processes to support robust, compliant, and cost-effective production for products to be distributed in highly regulated markets.
Responsibilities
- Lead and manage the Technical Operations team.
- Responsible for design and execution of process verification and validation activities (IQ/OQ/PQ, PV, PPQ) aligned with regulatory expectations (FDA QSR, IVDR)
- Implement a quality by design (QBD) approach and mindset into the team.
- Ensure processes are capable, reproducible, and scalable.
- Manage transfer of products from R&D to manufacturing.
Qualifications
Education: Bachelor’s or Master’s degree in Engineering, Biotechnology, Life Sciences, or related field.
Experience: 8+ years experience in manufacturing, process development, or technical operations
Competencies:
Strong experience in:
- Process validation (IQ/OQ/PQ, PPQ) & Scale-up and technology transfer in regulated environments (IVD, medical devices, pharma, biotech).
- Statistical analysis and process capability tools.
- Proven track record of delivering robust, scalable manufacturing processes.
Travel (If Applicable): Minimal