Pilot Plant Operations Specialist

4 weeks ago

Rahway, United States Merck Sharp & Dohme Full time

**SSO Operations Specialist Job Description**

The Small Scale Organics (SSO) Pilot Plant is a GMP (Good Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and Development (SM PR&D) organization. The SSO pilot plant enables gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development, and seamless technology transfer to commercial sites.

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 to meet SSO objectives and customer requirements. The position is responsible for implementing actions to meet S&E and GMP requirements. This position is also responsible for ensuring facility readiness for batch processing and shares accountability for the building performance. Ultimately, this position is expected to work cooperatively with the SSO leadership team and SSO partners to drive overall success and performance of the building, and ultimately strong support for the overall SM PR&D pipeline.

**Responsibilities**:
Under the scientific direction of a facility lead, the Operations Specialist will participate in equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at a pilot scale, process knowledge capture, and troubleshooting equipment with the aim of advancing process development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of a variety of reagents, solvents, and active pharmaceutical ingredients during “wet chemistry” operations (performing chemical reactions, extractions, distillations, crystallizations, filtration, drying, etc.) as well as dry powder processing (e.g., dry milling).
- Ensure processes are run within the capability constraints of the facility.
- Ensure facility readiness with respect to cleaning (including documentation and execution), dummy run and 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 a continuous improvement mindset.
- Collaborate with all building staff to share and align on best practices.
- Actively investigate problem statements and safety observation reports (SORs) to promote fast and efficient closure.
- As needed, safely perform High Risk Work involving hazardous energy control.
- Identify and follow through on opportunities to improve building flexibility, efficiency, compliance, and safety.
- Author lessons learnt and summary reports to capture knowledge gained.
- Mentor and help train rotational and new employees.
- This position’s primary focus is executing batch production work. Additional responsibilities include coordination, planning, documentation, and other facility improvement activities.

**Position 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 2024 - 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.

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**NOTICE FOR INTERNAL APPLICANTS**

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no

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