Senior Specialist Engineering, Sterile/Liquids (Onsite)
This role is based in the Sterile/Liquids Pilot Plants (SLP) in Bldg. 17 at West Point, part of the Pharmaceutical Sciences organization. The SLP supports the formulation and filling of clinical, stability, and developmental supplies for vaccines, small molecules, and therapeutic proteins. The team interfaces with multiple internal groups, including Research Laboratories, Sterile/Liquids Commercialization (SLC), commercial supply, and other pilot plants within the PharmSci network. The SLP supplies are critical for new product process development, scale-up, launch, transfer to the supply network, and optimization of existing commercial products.
About the role
The Process Engineer (PE) provides technical input on sterile processes from a facility and operational standpoint, offers manufacturing project management oversight, and applies GMP expertise to ensure timely availability of clinical supplies and development batches. This role serves as the main interface with development scientists for manufacturing sterile liquid clinical and development batches in the SLP. Additional responsibilities include deviation management, process improvement projects, implementation of new technologies, and process design.
Responsibilities
- Provide technical input on sterile processes from a facility and operational perspective.
- Oversee manufacturing project management and ensure GMP compliance.
- Interface with development scientists for sterile liquid clinical and development batch manufacturing.
- Manage deviations and lead process improvement projects.
- Implement new technologies and contribute to process design.
- Prepare technical documentation, including batch records, investigations, and protocols.
Requirements
- Bachelor's of Science in Chemical Engineering, Chemistry, Biology, or a related scientific field (required).
- Minimum of 3 years in a technical or operations support role.
- Experience with sterile process manufacturing and/or formulation development.
- Knowledge of manufacturing equipment and Good Manufacturing Practices (GMP).
- Project management experience.
- Strong analytical problem-solving and cross-functional leadership skills.
- Proficiency in technical writing, including batch documentation, investigations, and protocols.
Skills
- Adaptability
- Analytical Testing
- Batch Production Records
- Biologics
- Chemical Engineering
- Chemistry
- Clinical Manufacturing
- Cross-Functional Project Management
- Data Analysis
- Detail-Oriented
- Deviation Management
- Documentation Preparation
- Drug Formulations
- Equipment Qualification
- Functional Management
- Good Manufacturing Practices (GMP)
- Manufacturing Processes
- Problem Identification
- Process Design
- Process Development (PD)
- Process Engineering
- Process Hazard Analysis (PHA)
- Process Optimization
Pay
The salary range for this role is $117,000.00 - $184,200.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Benefits
We offer a comprehensive package of benefits, including:
- Medical, dental, vision, and other insurance benefits (for employee and family).
- Retirement benefits, including 401(k).
- Paid holidays, vacation, and compassionate and sick days.
More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Location: West Point, PA. This role is eligible for ERP. No relocation or visa sponsorship is provided. This is a regular, full-time position with no travel requirements.