Senior Process Engineer/Scientist in North East

Organon is hiring a Senior Process Engineer/Scientist to join our world class manufacturing site in Cramlington, Northumberland. In this role, you will be responsible for the management and execution of Technical Operations projects which can include technical transfers, new equipment, supplier item qualification, cleaning and continuous improvement initiatives. The successful candidate will provide leadership, governance, and technical expertise to ensure that projects or activities impacting Technical Operations are delivered safely, compliantly and in line with required timelines and budget.

Role Responsibilities

• Lead the site Cleaning Validation Program, including development, execution and lifecycle management of cleaning validation and cleaning verification activities for manufacturing and packaging equipment.
• Manage complex investigations and follow up issues arising from deviations, establishing assignable causes for atypical events and propose 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.
• Coordinates/Mentors/Implements training of other members of the Technical Services group and educating other areas on the roles and responsibilities of Technical Services.
• Lead Operational Excellence activities – continuous improvement, systems robustness with use of appropriate LSS tools and 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 environment.
• Effective time management and organisation skill to aid prioritisation, resource allocation and meet project deadlines.
• Proven logical, analytical approach to problem solving with high complexity with good root cause analysis to develop new systems and ways of working, utilising Lean Six Sigma principals.

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.