Process Scientist/Engineer (FTC)

Organon LLC; Cramlington; On-site; GBP 42,000 - 65,000; Full time

Job summary

Organon is hiring a Process Scientist/Engineer for our manufacturing site in Cramlington, Northumberland. This fixed-term role (24 months) covers technical operations projects, transfers, equipment qualification, cleaning validation, and continuous improvement to ensure safe, compliant, on-time delivery within budget.

Key duties include technical process expertise, issue investigation, validation coordination, cross-functional collaboration, and training within the Technical Services group, with

Qualifications

• Demonstrable experience in pharmaceutical manufacturing or process support.
• Positive approach to teamwork and continuous improvement.
• Proven ability to communicate, influence and work effectively in cross-functional environments.
• Project management skills for lean manufacturing projects.
• Strong time management and organisational skills to meet deadlines.
• Ability to anticipate issues and elevate effectively.
• Logical, analytical problem solving with root cause analysis using Lean Six Sigma principles.
• Influencing skills to build relationships and drive change.

Responsibilities

• Provides technical expertise for all processes involved in packaging on site, including transfers, specification/testing/qualification and operation of new capital process equipment, ensuring timely use and validation.
• Investigate deviations and establish causes, proposing actions to minimise rework and improve process capability.
• Coordinate process and cleaning validation activities, assist with validation protocols and oversee in-process sampling.
• Participate in cross-functional site teams on specialist topics with minimal support.
• Assist in site compliance with policies, procedures, guidelines and SOPs; provide input as appropriate.
• Support training of Technical Services staff and educate other areas on roles and responsibilities.
• Support Quality Systems and Quality Risk Management principles within Technical Services.
• Champion Operational Excellence, continuous improvement, and robust systems with Lean Six Sigma mindset.

Skills

Pharmaceutical manufacturing

Team collaboration

Communication skills

Project management

Time management

Root cause analysis

Lean Six Sigma

Influencing skills

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.

This position is offered on a 24 month fixed term contract basis.

Role Responsibilities

• Provides technical expertise for all processes involved in the 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 elevate 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: Who We Are

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.

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.

Employee Status: Temporary (Fixed Term)

Relocation: No relocation

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements: Shift: Not Indicated

Number of Openings: 1