LC-MS Technical Operations Lead for Process Validation

Waters Corporation; Wexford; On-site; EUR 90,000 - 120,000; Full time

Job summary

Waters Corporation's Advanced Diagnostics (ADx) Division seeks a Technical Operations Manager to lead end-to-end process verification, validation, scale-up and technology transfer for LC-MS manufacturing in regulated markets.

Responsibilities include building a high-performing team, ensuring IQ/OQ/PQ activities meet FDA QSR and IVDR standards, driving QBD mindset, and transferring products from R&D to production to enable robust, cost-effective operations.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Biotechnology, Life Sciences, or related field.
• 8+ years experience in manufacturing, process development, or technical operations.
• Strong experience in process validation (IQ/OQ/PQ) and scale-up in regulated environments.
• Track record delivering robust, scalable manufacturing processes.

Responsibilities

• Lead and manage the Technical Operations team.
• Design and execute process verification and validation activities (IQ/OQ/PQ, PV, PPQ) aligned with regulatory expectations (FDA QSR, IVDR).
• Implement a quality by design (QBD) mindset.
• Ensure processes are capable, reproducible, and scalable.
• Manage transfer of products from R&D to manufacturing.

Skills

Process validation

Scale-up

Technology transfer

Statistical analysis

Process capability

Proven track record

Education

Bachelor’s or Master’s degree in Engineering, Biotechnology, Life Sciences

Job description

Waters Corporation's Advanced Diagnostics (ADx) Division seeks a Technical Operations Manager to lead end-to-end process verification, validation, scale-up and technology transfer for LC-MS manufacturing in regulated markets.

Responsibilities include building a high-performing team, ensuring IQ/OQ/PQ activities meet FDA QSR and IVDR standards, driving QBD mindset, and transferring products from R&D to production to enable robust, cost-effective operations.