Senior Specialist, Engineering

Merck•Rahway, NJ

1d•$117,000 - $184,200•Onsite

About The Position

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.

Requirements

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.
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 small molecule drug substance and/or biologics 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.
Adaptability
Analytical Testing
Chemical Engineering
Chemistry
Data Analysis
Detail-Oriented
Deviation Investigations
Deviation Management
Driving Continuous Improvement
Equipment Qualification
Fast-Paced Environments
GMP Compliance
Good Manufacturing Practices (GMP)
Immunochemistry
Industrial Hygiene
Inventory Management
Pharmaceutical Biology
Pharmaceutical Development
Process Design
Process Hazard Analysis (PHA)
Process Optimization
Production Process Development
Root Cause Analysis (RCA)
Strategic Thinking

Nice To Haves

Operations experience in a GMP clinical supply facility (intermediate scale or pilot plant) or manufacturing environment.
Experience providing technical mentorship.
Experience supporting compliance investigations and change management.
Experience working with Quality systems.
Experience working in an environment with an Automation System (DeltaV, PLC, etc.).

Responsibilities

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.