Associate Specialist, Operations (Onsite)

MSD • Rahway, NJ

2d • $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 internal experience with scale-up of GMP manufacturing steps, demonstration of new manufacturing technology and processes, training for improved manufacturing process development, and technology transfer to commercial sites.

The Operations Specialist provides hands-on assistance with daily production while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMPs). The role implements actions to meet these 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’s performance and the SM PR&D pipeline.

The primary focus is batch production. Other duties include coordination, planning, documentation, and facility improvement activities. The role works onsite five days a week, with 8-hour shifts rotating between first and second shift on alternating weeks. Occasional overtime may be required based on business needs.

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 December 2026; alternatively, a high school diploma/GED and 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 interfacing 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 a week on 8-hour shifts alternating 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 chemical process scale-up from laboratory to pilot scale.
• Familiarity with cGMPs, Good Documentation Practices (GDPs), and S&E regulations as they apply to pharmaceutical development.
• Lean Six Sigma training or certification.

Responsibilities

• Participate in equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at pilot scale, process knowledge capture, and equipment troubleshooting.
• Handle reagents, solvents, and active pharmaceutical ingredients during wet chemistry operations, including reactions, extractions, distillations, crystallizations, filtration, and drying, as well as dry powder processing such as dry milling.
• Ensure processes are run within the facility’s capability constraints.
• Maintain facility readiness for cleaning, including documentation and execution, 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.
• Provide input on process setups.
• Provide regular feedback to peers to promote continuous improvement and collaborate with building staff to share and align on best practices.
• Investigate problem statements and safety observation reports (SORs) to promote timely 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.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Eligible for annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree