Process Engineer/Scientist

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

Job Description

Organon is hiring a Process Scientist/Engineer to join our team based at our world class manufacturing site in Cramlington, Northumberland. In this role, you will be responsible for the execution of Technical Operations projects which can include technical transfers, new equipment, supplier item qualification, cleaning and continuous improvement initiatives. You will work to provide 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

• 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.

Qualifications, Skills and Experience

• 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.

Secondary Job Description

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.

Additional Information

Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites No Travel Required Flexible Work Arrangements: Work Week Shift: 1st - Day Valid Driving License: No Hazardous Material(s): Number of Openings: 1

At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.