Specialist, Operations Training

The Position

We are looking for a Specialist, Operations Training to support the development, qualification and continuous improvement of production staff at our Pirbright manufacturing site. This role plays a key part in ensuring compliance, training quality and operational excellence across aseptic production processes in alignment with EU, UK, USDA, GMP, biosafety and HSE standards.

The Specialist, Operations Training will be the primary evaluator for OJT activities, actively involved in delivering technical and compliance training, and supporting improvement initiatives, investigations, audits and documentation quality as well as working closely with Production, QA, Tech Transfer and other cross‑functional teams to maintain a high‑performing, fully qualified workforce in a highly regulated environment.

This is a fixed-term contract until 31st December 2027.

Key Responsibilities

Training & Qualification

• Deliver classroom and hands‑on technical training across all aspects of aseptic production, including SIP/autoclave, cleaning, equipment handling and compliance requirements.
• Lead the design, execution and evaluation of OJT (On‑the‑Job Training) curricula, ensuring all training remains current and aligned with global standards.
• Serve as the primary evaluator for aseptic work, Master Batch Record compliance and technical certifications for critical tasks.
• Conduct job task analyses and ensure training documentation is accurate and audit‑ready.

Process Improvement & Operational Excellence

• Lead and support continuous improvement projects using Lean, Six Sigma and the 5‑Step Problem‑Solving Method.
• Provide technical and compliance expertise to support change controls, Tech Transfer activities and cross‑functional improvement initiatives.
• Communicate project status, risks and opportunities to site leadership.

Investigations & Compliance

• Lead or support investigations into production‑related deviations, identifying root causes and recommending CAPA actions.
• Prepare deviation and out‑of‑specification reports in line with GMP, EU, UK and USDA requirements.
• Ensure documentation is completed contemporaneously and supports high manufacturing standards.

Cross‑Functional Collaboration

• Partner with supervisors to identify training needs and capability gaps.
• Align training priorities through Tier 1 and Tier 2 meetings.
• Coordinate closely with QA, Production, Change Control, MSAT and other departments to support operational readiness.

Biosafety & EHS

• Ensure strict adherence to all biosafety rules and required communication protocols.
• Investigate EHS incidents, complete risk assessments and fulfil mandatory Health & Safety training.
• Support audit readiness and participate in internal/external inspections.

Systems & Documentation

• Complete and maintain accurate entries in LIMS, SAP/ERP and other training or compliance systems.
• Audit Master Batch Records, training documentation and process data for accuracy and completeness.

Requirements

Education

• Degree in a scientific discipline preferred; equivalent experience will be considered.

Skills & Experience

• Relevant experience in cGMP aseptic production, biomanufacturing or a comparable regulated environment and demonstrated capability to operate effectively within compliance‑driven processes and technical workflows.
• Proven experience supporting production processes and delivering OJT training.
• Demonstrated competence in leading investigations, completing CAPAs and driving process improvement initiatives.
• Strong communication skills and the ability to mentor and train others.
• Solid understanding of GMP, EU/UK/USDA guidelines, biosafety and HSE requirements.
• Excellent attention to detail and strong documentation skills.
• Proficiency with MS Office; experience with SAP/ERP and LIMS is an advantage.

Competencies

• Effective individual contribution, demonstrated through a structured, methodical approach and ownership of key deliverables.
• Proactive, solutions‑focused mindset with a drive for continuous improvement.
• Ability to challenge existing practices and support a culture of excellence.
• Strong organizational skills and the ability to manage multiple priorities.

WHY THIS IS A GREAT PLACE TO WORK

Boehringer Ingelheim has been recognised as a Top Employer in the UK, demonstrating our commitment to building an exceptional workplace through strong people practices and supportive HR policies.

To learn more about why BI is a great place to work, visit:

https://www.boehringer-ingelheim.co.uk/careers/uk-careers/why-great-place-work

A Disclosure and Barring Service (DBS) check will be required for the successful candidate. Any offer of employment will be subject to satisfactory DBS certificate.