Associate Specialist, Operations (Onsite)

MSD•Rahway, NJ

9d•$71,900 - $113,200•Onsite

About The Position

The Small Scale Organics (SSO) Pilot Plant is a GMP manufacturing facility within the Small Molecule Process Research and Development organization. It supports scale-up experience, demonstration of new manufacturing technologies and processes, manufacturing process development training, and technology transfer to commercial sites. The Operations Specialist provides hands-on assistance with daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMPs). The role helps meet SSO objectives and customer requirements, implements actions to satisfy S&E and GMP requirements, ensures facility readiness for batch processing, and shares accountability for building performance. The specialist works cooperatively with SSO leadership and partners to support the building and the broader SM PR&D pipeline. Under the scientific direction of a facility lead, the specialist participates in pilot-scale equipment setups, raw-material sampling and subdivisions, solution preparation, batch planning and execution, process knowledge capture, and equipment troubleshooting. Work may involve wet chemistry operations such as reactions, extractions, distillations, crystallizations, filtration, and drying, as well as dry powder processing such as dry milling. The primary focus is batch production, with additional coordination, planning, documentation, and facility-improvement activities. The position works onsite five days per week on 8-hour shifts that rotate between first and second shift on alternating weeks. Occasional overtime may be required based on business needs. The primary location is Rahway, New Jersey.

Requirements

Associate in Science, Associate in Applied Science (ideally in Process Technology), or a higher degree in a relevant technical field, with expected completion by June 2026; alternatively, a high school diploma or GED plus at least four years of relevant experience in pharmaceutical, chemical, petrochemical, or food processing/manufacturing.
Strong communication skills to discuss technical problems and a collaborative mindset for working with cross-functional teams.
Strong mechanical aptitude.
Proficiency in technical writing and word-processing, spreadsheet, graphing, and presentation software.
Ability to work onsite five days per week.
Ability to work 8-hour shifts rotating between first and second shift on alternating weeks.
Ability to work occasional overtime based on business needs.

Nice To Haves

Operations experience in a pilot plant or manufacturing environment.
Understanding of or experience with scaling chemical processes from laboratory to pilot scale.
Familiarity with cGMP administration, Good Documentation Practices, and S&E regulations as they apply to pharmaceutical development.
Lean Six Sigma training or certification.

Responsibilities

Participate in equipment setup, raw-material sampling and subdivisions, solution preparation, batch-processing planning and execution at pilot scale, process knowledge capture, and equipment troubleshooting.
Carry out wet chemistry operations, including chemical reactions, extractions, distillations, crystallizations, filtration, and drying, and dry powder processing such as dry milling.
Ensure processes are operated within the capability constraints of the facility.
Maintain facility readiness through cleaning execution and documentation, batch execution readiness, building housekeeping, and consumable inventory management.
Provide input to incident root-cause analysis, reporting, and action items.
Facilitate and drive building improvement projects and closure of corrective and preventive actions.
Provide input on process setups.
Give regular feedback to peers to promote continuous improvement.
Collaborate with building staff to share and align on best practices.
Investigate problem statements and safety observation reports to support timely and efficient closure.
Safely perform high-risk work involving hazardous-energy control as needed.
Identify and follow through on opportunities to improve building flexibility, efficiency, compliance, and safety.
Author lessons learned and summary reports to capture knowledge gained.
Mentor and help train rotational and new employees.