Pharma Process Engineer: Ops Excellence & Validation

Organon LLC; Cramlington; On-site; GBP 55,000 - 75,000; Full time

Job summary

Organon is seeking a Process Scientist/Engineer to join our world-class manufacturing site in Cramlington, Northumberland. You will execute Technical Operations projects, including transfers, equipment qualification, and process improvements, ensuring safe, compliant, and timely delivery.

You will provide technical expertise across manufacturing and packaging processes, support validation activities, and contribute to cross-functional teams while driving quality and continuous improvement within

Qualifications

• Demonstrable experience in Pharmaceutical manufacturing, preferably in a process support environment and/or a minimum of degree in Science or Engineering Discipline or equivalent.
• Positive approach to team working and continuous improvement.
• Proven ability to communicate, influence and work effectively in both individual and cross functional environment.
• Project Management skills for projects in a lean manufacturing environment.
• Effective time management and organisation skill to aid prioritisation, resource allocation and meet project deadlines.
• Ability to anticipate potential issues and escal ate effectively.
• Can demonstrate logical, analytical approach to problem solving with good root cause analysis to develop new systems and ways of working, utilising Lean Six Sigma principals.
• Influencing skills to build and maintain relationships by understanding stakeholder requirements to drive positive change within the organisation.

Responsibilities

• Provides technical expertise for all processes involved in the manufacturing and packaging of products on site, including technical transfers, assistance with specification, testing, qualification, and operation of new capital process equipment, ensuring timely use, efficient performance, successful validation and optimal process capability.
• Investigate and follow up issues arising from manufacturing, packaging or laboratory deviations, establishing assignable causes for atypical processing events and propose appropriate actions to minimise rework and improve process capability.
• Co-ordinate process and cleaning validation activities on site, provide technical manufacturing assistance with the preparation of validation protocols and oversee in-process validation sampling.
• Participate/co-ordinate in cross-functional teams for the site in relation to specialist topics, with minimal support.
• Assist in site compliance with the standards in policies, procedures, guidelines and SOPs and comment / author as appropriate.
• Implements and supports training of other members of the Technical Services group and educating other areas on the roles and responsibilities of Technical Services.
• Quality Systems – Technical Support to Quality and Compliance Initiatives with consideration for Quality Risk Management principals.
• Champion Operational Excellence activities – continuous improvement, systems robustness with use of appropriate LSS tools and innovative mindset.

Skills

Pharmaceutical manufacturing

Process engineering

Project management

Communication

Lean Six Sigma

Root cause analysis

Team collaboration

Time management

Education

Science or Engineering degree

Job description

Organon is seeking a Process Scientist/Engineer to join our world-class manufacturing site in Cramlington, Northumberland. You will execute Technical Operations projects, including transfers, equipment qualification, and process improvements, ensuring safe, compliant, and timely delivery.

You will provide technical expertise across manufacturing and packaging processes, support validation activities, and contribute to cross-functional teams while driving quality and continuous improvement within