Organon
Senior Process Engineer/Scientist
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Job Description
Organon is hiring a Senior Process Engineer/Scientist to join our world-class manufacturing site in Cramlington, Northumberland. In this role, you will be responsible for the management and execution of Technical Operations projects which can include technical transfers, new equipment, supplier item qualification, cleaning, and continuous improvement initiatives.
The successful candidate will provide leadership, governance, and 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
- Lead the site Cleaning Validation Program, including development, execution, and lifecycle management of cleaning validation and cleaning verification activities for manufacturing and packaging equipment.
- Manage complex investigations and follow up issues arising from deviations, establishing assignable causes for atypical events, and propose appropriate actions to improve process capability.
- Develop strategies for validation activities on site, provide technical manufacturing assistance with the preparation of validation protocols, and oversee in-process validation sampling.
- Lead site compliance with the standards in policies, procedures, guidelines, and SOPs and comment/author as appropriate.
- Coordinates/Mentors/Implements training of other members of the Technical Services group and educating other areas on the roles and responsibilities of Technical Services.
- Lead Operational Excellence activities – continuous improvement, systems robustness with the use of appropriate LSS tools, and innovative mindset.
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Qualifications, Skills, and Experience
- Significant experience in cleaning validation within a GMP pharmaceutical manufacturing environment.
- Demonstrable knowledge of regulatory expectations relating to cleaning validation, including EU GMP Annex 15, PIC/S guidance, FDA guidance, and risk-based approaches to setting cleaning limits.
- Demonstrable experience in Pharmaceutical manufacturing, preferably in a process support environment.
- Degree in Science or Engineering Discipline or equivalent.
- Proven ability to communicate, influence, and work effectively in both individual and cross-functional environments.
- Effective time management and organization skills to aid prioritization, resource allocation, and meet project deadlines.
- Proven logical, analytical approach to problem-solving with high complexity, with good root cause analysis, to develop new systems and ways of working, utilizing Lean Six Sigma principals.
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.
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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): No
Number of Openings:
- 1
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