Senior Process Engineer/Scientist in Cramlington

Job Title

Senior Process Engineer/Scientist

Location

Cramlington, Northumberland

Responsibilities

• Lead the site Cleaning Validation Program, including the development, execution, and lifecycle management of cleaning validation and cleaning verification activities for manufacturing and packaging equipment.
• Manage complex investigations and follow up on issues arising from deviations, establishing assignable causes for atypical events and proposing appropriate actions to improve process capability.
• Develop strategies for validation activities on site, provide technical manufacturing assistance with the preparation of validation protocols, and oversee in‑process validation sampling.
• Lead site compliance with the standards in policies, procedures, guidelines and SOPs and comment/author as appropriate.
• Coordinate, mentor, and implement training for members of the Technical Services group and educate other areas on the roles and responsibilities of Technical Services.
• Lead Operational Excellence activities – continuous improvement, systems robustness using appropriate LSS tools and an innovative mindset.

Qualifications, Skills and Experience

• Significant experience in cleaning validation within a GMP pharmaceutical manufacturing environment.
• Demonstrable knowledge of regulatory expectations relating to cleaning validation, including EU GMP Annex 15, PIC/S guidance, FDA guidance and risk‑based approaches to setting cleaning limits.
• Demonstrable experience in pharmaceutical manufacturing, preferably in a process support environment.
• Degree in Science or Engineering Discipline or equivalent.
• Proven ability to communicate, influence and work effectively in both individual and cross‑functional environments.
• Effective time management and organisation skills to aid prioritisation, resource allocation and meet project deadlines.
• Proven logical, analytical approach to problem solving with high complexity, good root cause analysis to develop new systems and ways of working, utilising Lean Six Sigma principles.

As an equal opportunity employer, we welcome applications from candidates with a diverse background.