Process Scientist/Engineer

Organon LLC; Cramlington; On-site; GBP 45,000 - 65,000; Full time

Job summary

Organon LLC in Cramlington, Northumberland seeks a Process Scientist/Engineer to join our manufacturing site. You will provide technical expertise for packaging processes, support transfers, specification testing, qualification and operation of new capital equipment, ensuring validation and optimal process capability.

The role involves investigating deviations, coordinating validation activities, cross-functional teamwork, maintaining Quality Systems, and championing Operational Excellence and

Qualifications

• Degree in science or engineering or equivalent pharma experience.
• Experience in pharmaceutical manufacturing or process support.
• Strong problem-solving and analytical skills.

Responsibilities

• Provide technical expertise for packaging processes and new capital equipment validation.
• Investigate deviations and determine root causes to reduce rework.
• Coordinate process and cleaning validation activities and sampling.
• Participate in cross-functional site teams on specialist topics.
• Ensure compliance with policies, procedures, and SOPs; contribute through comments.
• Support training within Technical Services and educate other areas on roles.

Skills

Pharma manufacturing

Team collaboration

Communication

Project management

Lean Six Sigma

Root cause analysis

Problem solving

Influencing

Education

Science or Engineering degree

Job description

Organon is hiring a Process Scientist/Engineer to join our team based at our world class manufacturing site in Cramlington, Northumberland.

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.

Employee & Job Details

• 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

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.

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.