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 use of appropriate LSS tools and innovative mindset.
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 environment.
- Effective time management and organisation skill to aid prioritisation, 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, utilising Lean Six Sigma principals.
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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
No Travel RequiredFlexible Work Arrangements:
Work WeekShift:
1st - DayValid Driving License:
NoHazardous Material(s):
Number of Openings:
1Skills Required
- Significant experience in cleaning validation within a GMP pharmaceutical manufacturing environment
- Knowledge of regulatory expectations for cleaning validation including EU GMP Annex 15, PIC/S guidance, and FDA guidance
- Demonstrable experience in pharmaceutical manufacturing, preferably in a process support environment
- Degree in a Science or Engineering discipline or equivalent
- Proven ability to communicate, influence and work effectively in individual and cross-functional teams
- Effective time management and organisational skills to prioritise and meet project deadlines
- Logical, analytical problem solving with strong root cause analysis skills and use of Lean Six Sigma principles
Organon Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Organon and has not been reviewed or approved by Organon.
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Strong & Reliable Incentives — Quarterly bonuses and performance-based long-term incentives are frequently emphasized as meaningful components of total rewards, sometimes contrasted favorably with larger pharmaceutical firms. Recognition programs and an annual incentive process reinforce a pay-for-performance approach.
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Parental & Family Support — Twelve weeks of gender-neutral paid parental leave and twenty days of bereavement leave, including coverage for pregnancy loss, signal a robust family support offering. Caregiving concierge services and flexible leave practices further strengthen support for caregiving needs.
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Retirement Support — Retirement plans include employer contributions across many markets, with U.S. materials highlighting matching and additional company retirement contributions. This structure is presented as a core part of the financial benefits package.
Organon Insights
What We Do
Organon is a global healthcare company with a portfolio of therapies and products in women’s health, biosimilars, and established medicines across a wide array of conditions and diseases. Our mission is to deliver impactful medicines and solutions for a healthier every day. This site is intended for residents of the United States and its territories. You are reminded to protect yourself against recruiting fraud from individuals, organizations or other entities claiming to represent Organon. All official Organon recruitment emails will come from accounts formatted as [email protected] or [email protected], and Organon will never conduct interviews by chat or email, or make job offers through social media or online forums. All candidates for roles at Organon will first meet with a recruiter and interview team, via Teams or in person. Organon will never ask you to make financial transactions on its behalf or ask you to receive or ship packages or goods. For more information on adverse event reporting, visit http://bit.ly/AEReporting. To read our community guidelines, visit http://bit.ly/OrganonCommunityGuidelines. Follow us on Twitter at Organon (@OrganonLLC). Follow us on Instagram at Organon (@OrganonLLC).
