Process Engineer/Scientist

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 escalate 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. 

Search Firm Representatives Please Read Carefully 
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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:

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