Sr. Specialist, Engineering (Onsite)
$117,000–$184,200 year
On-siteRahway, New Jersey, United States
Job Summary
Lead sterile process engineering activities for the FLEx GMP clinical supply manufacturing facility, driving success through process tech transfers, scale-up activities, quality investigations, and change management. Author GMP standard operating procedures and protocols to support sterile clinical drug product operations while collaborating with development scientists, engineers, and quality representatives to ensure supply quality and process rigor. Manage complex formulations and enable pipeline flexibility through technical leadership and independent problem-solving. Based onsite in Rahway, New Jersey, this role supports the company's global health care mission in vaccine and drug product development.
Required Qualifications
- Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field
- Master's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field
- PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field
- Minimum of 5 years relevant experience
- Minimum of 3 years of relevant experience
- Excellent enterprise leadership skill demonstration
- Excellent interpersonal and communication skills, both verbal and written
- Experience in leading quality investigations and change management
- Familiarity with United States and European Union GMP and Safety compliance regulations
- Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture
- Ability to prepare Standard Operating Procedures (SOP) and current GXP documents
- Experience with quality systems
- Excellent organizational skills
- Desire and willingness to learn, contribute and lead
- Track-record of independent problem-solving
- Adaptability
- Analytical Testing
- Change Management
- Chemical Engineering
- Clinical Trials Operations
- Data Analysis
- Detail-Oriented
- Deviation Management
- Equipment Qualification
- GMP Compliance
- Good Manufacturing Practices (GMP)
- Medical Supply Management
- Medicinal Chemistry
- Pharmaceutical Sciences
- Process Design
- Process Hazard Analysis (PHA)
- Process Optimization
- Root Cause Analysis (RCA)
- Standard Operating Procedure (SOP)
- Standard Operating Procedure (SOP) Development
- Sterile Procedures
- Strategic Thinking
- Technical Leadership
- Technical Problem-Solving
- Valid Driving License
Desired Qualifications
- Experience with sterile GMP facility startup
- Knowledge of Investigational drug regulatory requirements
- Understanding of Clinical Supply Chain Operations
- Expertise in drug product aseptic processing, equipment, and sterile technique
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