Associate Specialist, Operations (Onsite)
Merck
Summary
The Small Scale Organics (SSO) Pilot Plant is a GMP manufacturing facility in the Small Molecule Process Research and Development organization. The SSO Operations Specialist will provide hands-on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMPs) requirements.
Job description
Responsibilities
- Participate in equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at pilot scale
- Handle reagents, solvents, and active pharmaceutical ingredients during wet chemistry operations (reactions, extractions, distillations, crystallizations, filtration, drying)
- Perform dry powder processing such as dry milling
- Ensure facility readiness with respect to cleaning, batch execution, building housekeeping, and consumable inventory
- Provide input for incident root cause analysis, reporting, and action items
- Facilitate and drive building improvement projects and corrective/preventative action closures
- Collaborate with building staff to share and align on best practices
- Investigate problem statements and safety observation reports (SORs)
- Safely perform High Risk Work involving hazardous energy control as needed
- Author lessons learnt and summary reports to capture knowledge gained
- Mentor and help train rotational and new employees
Qualifications
Education Minimum Requirement: Associate in Science, Associate in Applied Science (ideally in Process Technology), or higher degree in a relevant technical field of study with expected completion by June 2026 – or – High School Diploma/GED plus at least four (4) years of relevant experience in Pharmaceutical, Chemical, Petrochemical or Food Processing/Manufacturing.
Required Experience and Skills: Strong communication skills to discuss technical problems and a collaborative mindset to interface with cross-functional teams. A strong mechanical aptitude. Proficiency in technical writing and the use of word processing, spreadsheet, graphing, and presentation software. This role requires working on 8-hour shifts that rotate between 1st and 2nd shift on alternating weeks throughout the year. Onsite presence is required five days a week. Occasional overtime work may be required based on business needs.
Preferred Experience and Skills: Operations experience in pilot plant or manufacturing environment. Understanding of/Experience with process scale-up of chemical processes, moving from the laboratory to the pilot scale. Familiarity with the administration of cGMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to pharmaceutical development. Lean Six Sigma Training / Certification.
Requirements
- Associate in Science, Associate in Applied Science (ideally in Process Technology), or higher degree in a relevant technical field of study with expected completion by June 2026, or High School Diploma/GED plus at least four (4) years of relevant experience in Pharmaceutical, Chemical, Petrochemical or Food Processing/Manufacturing
- Strong communication skills to discuss technical problems
- Collaborative mindset to interface with cross-functional teams
- Strong mechanical aptitude
- Proficiency in technical writing and use of word processing, spreadsheet, graphing, and presentation software
- Ability to work 8-hour shifts rotating between 1st and 2nd shift on alternating weeks
- Onsite presence five days a week
- Occasional overtime as required
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.