PAT Specialist

1007 Organon Pharma (UK) Limited; Cramlington; On-site; GBP 70,000 - 90,000; Full time

Job summary

Organon LLC is hiring a PAT Specialist to join our manufacturing site in Cramlington, Northumberland. You will act as the site’s PAT subject matter expert, driving technical excellence, validation, and data stewardship for digital process data and PAT models across drug substance and product.

You will lead PAT projects, support technology transfer and process validation, and train colleagues in PAT methodologies while ensuring compliance with cGMP and safety standards.

Qualifications

• Master’s degree in Sciences, Analytical Chemistry, or Chemical Engineering required.
• Working knowledge of chemometrics methodologies strongly preferred.
• Experience in international and multidisciplinary environments; cGMP knowledge preferred in pharma production and development.

Responsibilities

• Provide PAT support for inline production, including NIR spectroscopy, in-process testing, and real-time release.
• Deliver and implement PAT projects across cross-functional teams, including PoC activities with internal and external partners.
• Support investigations into PAT-related issues, performing root-cause analysis and contributing to statistical and multivariate data analysis.
• Assist with technology transfer, process validation, and the specification, installation, and qualification of PAT equipment.
• Ensure compliance with PAT standards, policies, and SOPs, preparing and reviewing required documentation.
• Contribute to training by delivering PAT learning sessions and supporting colleagues in developing PAT knowledge.

Skills

Chemometrics

Education

Master’s degree in Sciences, Analytical Chemistry, or Chemical Engineering

Job description

Job Description

Organon is hiring a PAT Specialist to join our world class manufacturing site in Cramlington, Northumberland. As the site’s subject matter expert for Process Analytical Technology (PAT), the PAT Specialist plays a key role in driving technical excellence, innovation, and robust manufacturing performance. Working within the Pharmaceutical Technical Operations (PTO) team and in partnership with the global PAT network, this role ensures the effective generation, validation, and stewardship of digital process data, control strategies, and PAT measurement models. Collaborating closely with colleagues across Operations, Quality, and Technical functions, the PAT Specialist delivers comprehensive expertise for both drug substance and drug product. They lead and support PAT projects to enable safe, compliant, and timely delivery, while promoting continuous skills development across the site. The role is actively involved in process development, investigations, and problem-solving activities, as well as facilitating Technology Transfer and Validation for new and existing processes. Responsibilities also include training colleagues in PAT methodologies and supporting the specification, design, installation, and commissioning of new equipment.

Role Responsibilities

• Provide PAT support for inline production, including NIR spectroscopy, in process testing, and real time release.
• Deliver and implement PAT projects across cross functional teams, including PoC activities with internal and external partners.
• Support investigations into PAT related issues, performing root-cause analysis and contributing to statistical and multivariate data analysis.
• Assist with technology transfer, process validation, and the specification, installation, and qualification of PAT equipment.
• Ensure compliance with PAT standards, policies, and SOPs, preparing and reviewing required documentation.
• Contribute to training by delivering PAT learning sessions and supporting colleagues in developing foundational PAT knowledge.
• Represent the site in global PAT forums, sharing best practice and supporting strategic initiatives.
• Drive continuous improvement by enhancing process robustness, supporting Quality Risk Management, and ensuring all PAT activities meet Safety, Health, Environmental, and Financial requirements.

Skills, Qualifications & Experience

• Master’s degree in Sciences, Analytical Chemistry, or Chemical Engineering required with applicable experience.
• Working knowledge of chemometrics methodologies is strongly preferred.
• Must be highly flexible and possesses relevant experience in working in an international and multidisciplinary environment and able to support the needs of reliable production and supply.
• Working knowledge of current Good Manufacturing Practices (cGMP) preferred and pharmaceutical production and development technologies.

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: Domestic 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

At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.