Process Scientist/Engineer

Organon; Cramlington; On-site; GBP 60,000 - 90,000; Full time

Job summary

Organon, based at our world-class manufacturing site in Cramlington, Northumberland, is seeking a Process Scientist/Engineer to lead technical operations projects including transfers, new equipment qualification, cleaning, and continuous improvement initiatives.

You will provide technical expertise to ensure on-time, compliant delivery within safety and budget constraints, collaborating with cross-functional teams and driving process capability improvements.

Qualifications

• Experience in pharmaceutical manufacturing, preferably in a process support environment or a science/engineering degree.
• Ability to communicate and influence effectively in cross-functional settings.
• Lean Six Sigma knowledge and problem-solving approach.

Responsibilities

• Provides technical expertise for processes involved in packaging, including transfers, testing, qualification and operation of new capital equipment.
• Investigates deviations, identifies root causes and proposes corrective actions to improve process capability.
• Co-ordinates process and cleaning validation activities and oversees validation sampling.
• Participates in cross-functional site teams on specialist topics with minimal supervision.
• Supports site compliance with policies, procedures, guidelines and SOPs.
• Implements training within Technical Services and educates other areas on roles and responsibilities.
• Supports Quality and Compliance initiatives with Quality Risk Management principles.
• Champions Operational Excellence and continuous improvement using Lean Six Sigma tools.

Skills

Pharma manufacturing

Process support

Lean Six Sigma

Project management

Cross-functional collaboration

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 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.

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.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship:

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

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings: 1