Pilot Plant Process Engineer, Senior 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 Pilot Plant is seeking a highly motivated and technically focused individual to work in a fast-paced job that provides a high degree of technical and project management responsibility.  

This SSO Process Engineer role within the SSO Pilot Plant leverages significant depth and breadth of scientific, technical, and operational experience to support facility operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead other staff in the pilot plant as needed. The position is responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well as ensuring facility readiness for batch processing. In addition, this position is expected to work cooperatively with the SSO leadership team and SSO partners to drive overall success of the pilot plant. The Process Engineer position reports to a Facility Leader and the successful candidate will be an integral member of the SSO process and production team at the Rahway, NJ facility.

Responsibilities of the role include but are not limited to:

• Prepare for and support batch processing readiness and execution activities.

• Prepare, review, and/or approve GMP Documentation as appropriate.

• Author/Approve Standard Operating Guidelines and Procedures.

• Support equipment and facility maintenance activities.

• Support equipment setup and cleaning and raw material inventory management activities.

• Support API release, and initiate, track and/or execute shipment of GMP materials.

• Foster a culture of collaboration, learning, and innovation.

• Serve as a technical mentor and process team member supporting the SSO Pilot Plant.  Mentor and help train rotational and new employees.

• Supervise staff performing GMP activities and deliver training as needed.

• Support deviation investigations, corrective/preventative action closures, and building initiatives as appropriate.

• Collaborate closely with the development engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and enable flexibility and speed of the Company’s pipeline.

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

• Provide regular feedback to peers to promote a continuous improvement mindset and collaborate with all building staff to share and align on best practices.

• Author lessons learnt through after action review summaries or other reports to capture knowledge gained.

• Drive new technology development projects through participation in equipment design and testing as well as preparation, review, and completion of GMP documentation.

• Support compliance with Industrial Hygiene (IH) program by leading or participating in IH sampling activities for new or existing equipment.

• Support data rich experimentation at pilot scale via process analytical technologies (PAT) implementation in the SSO.

Education Minimum Requirement: 

• Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 4 years relevant experience, or a Master’s degree with 3 years of relevant experience, or a PhD degree with 1 year of relevant experience.

Required Experience and Skills:

• Ability to convert new drug substance process needs to an executable series of steps and procedures to enable acceptable product manufacture.

• Familiarity with the administration of cGMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to pharmaceutical development.

• Experience with process development and scale-up, moving from laboratory to pilot scale.

• Effective interpersonal and communication skills, both written and verbal.

• Excellent time management and organizational skills.

• Desire and willingness to learn, contribute, and lead.

• Track-record of independent problem-solving.

Preferred Experience and Skills:

• Operations experience in a GMP clinical supply facility (intermediate scale or pilot plant) or manufacturing environment.

• Experience providing technical mentorship.

• Experience with process development and scale-up as it pertains to small molecule drug substance and/or biologics 

• Experience supporting compliance investigations and change management.

• Experience working with Quality systems.

• Experience working in an environment with an Automation System (DeltaV, PLC, etc.).

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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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