Pilot Plant Operations Specialist, Small Scale Organics (3rd shift)

Job Description

The Small Scale Organics Pilot Plant is a (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 Good Manufacturing Practices 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 plus at least six (6) years of relevant experience – or –

• High School Diploma/GED plus at least eight (8) 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 a fixed (steady), 8-hour overnight 3rd shift 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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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listedhere.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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.

Employee Status:

Regular

Relocation: