The Role:
This role is responsible for designing, optimizing, and validating pharmaceutical manufacturing processes across the full product lifecycle — from lab-scale development through commercial production. The engineer will lead technology transfers, execute Commissioning, Qualification, and Validation (CQV) activities in compliance with cGMP standards, and author key documentation including validation protocols, batch records, and SOPs.
The position also involves managing multiple projects simultaneously, coordinating with vendors and contractors, and driving continuous improvement initiatives to enhance efficiency, quality, and safety.
The ideal candidate holds a BS in Chemical or Mechanical Engineering, has 2+ years of pharma industry experience in a cGMP environment, and brings strong communication and problem-solving skills. Experience with powder processing and process scale-up is a plus. Occasional U.S. travel (~10%) is required.
Process Design & Optimization
• Design, develop, and optimize manufacturing processes for pharmaceutical products
• Identify and implement opportunities to improve process efficiency, reduce waste, and enhance product quality
• Lead end-to-end technology transfers, managing the transition of drug manufacturing processes from lab scale to commercial scale
Commissioning, Qualification & Validation (CQV)
• Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety and regulatory compliance
• Deliver C&Q activities in alignment with project schedules and cGMP requirements
• Track and report progress of CQV efforts to project stakeholders
• Support execution of design reviews, commissioning, FATs, IQ, OQ, and PQ activities
• Coordinate with project contractors and equipment vendors to execute required testing
Documentation & Compliance
• Assist in the authoring and review Process Validation (PV) protocols, reports, batch records, and standard operating procedures (SOPs)
• Ensure all process activities comply with cGMPs, regulatory submissions, and internal quality standards
Project Planning & Coordination
• Manage multiple projects simultaneously through full process lifecycles, providing weekly status updates on progress, timelines and milestones
• Allocate project resources for efficient execution
• Coordinate support and logistics during CQV execution
Continuous Improvement & Problem Solving
• Investigate and resolve process deviations and out-of-specification (OOS) results
• Champion a culture of continuous improvement and operational excellence
• Participate in or lead cross-functional teams
Qualifications and Experience
Education
• Bachelor's degree (BS) in Chemical Engineering, Mechanical Engineering, or related discipline
Experience
• 2+ years of related experience in the Pharmaceutical industry
• Essential experience working in a cGMP (Good Manufacturing Practice) environment
• Experience with process validation and/or technology transfer
• Experience with pharmaceutical manufacturing equipment is preferred
• Experience with powder blending and powder processing a plus
• Background in process scale-up from lab/pilot to commercial manufacturing a plus
Skills & Attributes
• Outstanding oral and written communication skills with the ability to convey complex technical information clearly
• Strong problem-solving and analytical abilities
• Proven ability to manage multiple priorities and deliver results in a fast-paced environment
• Customer-focused mindset with a commitment to quality and safety
• Willingness and flexibility to travel throughout the U.S. (~10%)
EEO STATEMENT
It is the policy of Quest Products LLC to provide equal employment opportunity to all individuals regardless of their race, creed, color, religion, sex, age, national origin, disabilities, veteran status, marital status, sexual orientation, military status, genetic information, or any other characteristic protected by state or federal law.
Job Type: Full-time
Benefits:
Schedule:
Supplemental Pay:
This Company Describes Its Culture as: