Pilot Plant Process Supervisor, Specialist

Job Description

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

The SSO Process Supervisor assists on daily production activities while ensuring compliance with Safety, GMP, and Environmental requirements in addition to the existing labor contract to meet SSO objectives and customer requirements. The position is responsible for implementing process improvement actions to meet S&E (Safety & Environmental) and GMP requirements. This position is also responsible for ensuring facility readiness for API (Active Pharmaceutical Ingredient) processing and shares accountability for the building performance. Ultimately, this position is expected to work cooperatively with the SSO leadership team and cross-functional SSO partners to drive overall success and performance of the building. This role will also be responsible for the prioritization and assignment of daily activities for the operations staff.

Responsibilities:

• Ensure processes are run within the capability constraints of the facility.

• Execute batch processes as needed from either a hands-on role or a supervisory role.

• Ensure facility equipment readiness with respect to repair, cleaning (including documentation and execution), batch execution, building housekeeping, and consumable inventory.

• Write, issue, and review GMP documentation.

• Provide input for incident root cause analysis, reporting, and action items.

• Facilitate and drive building improvement projects and CAPA (Corrective Action and Preventive Action) completions.

• Provide input on and proficiently execute process setups.

• Provide regular feedback (both constructive and positive) 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 SORs (Safety Observation Reports) to promote fast and efficient problem resolution.

• Understand hazardous/high risk-work and issue permits as needed.

• Identify opportunities to improve building efficiency, compliance, and safety.

• Support training, mentoring, and coaching of operations staff.

Education Minimum Requirement: Bachelor's degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline with at least 2 years of relevant experience in a process development lab or pilot plant/manufacturing facility

— OR—

High school diploma with at least 6 years of relevant experience in a process development lab or pilot plant/manufacturing facility.

Required Experience and Skills:

• Mechanical aptitude and familiarity with chemical process development and process equipment.

• Effective communication skills and a collaborative mindset.

• Experience in conflict resolution and root cause analyses.

• Ability to build effective work relationships with a diverse workforce.

• Adaptable to a dynamic production environment.

• Relevant experience in a process development lab or pilot plant/manufacturing facility.

• 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:

• Understanding of and experience with current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and Safety & Environmental (S&E) regulations.

• Lean Six Sigma Training / Certification.

• Operations experience in pilot plant or manufacturing environment.

• Prior supervisor or mentor experience.

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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 listed here.

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.

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Requisition ID:R333801