Pharmaceutical Packaging Development Engineer

Granules•Manassas, VA

4d•Onsite

About The Position

This role involves working with R&D and customers on packaging configurations, understanding consumer choices, and optimizing designs for effectiveness and sustainability. The engineer will ensure packaging meets legal requirements, including labeling, safety, and environmental regulations. Key responsibilities include leading research for cost-effective packaging solutions, communicating with material suppliers for FDA filings, and managing experimental, scale-up, exhibit batch, and product launch activities. The position also focuses on improving packaging processes for sustainability and compliance, assisting with equipment modifications and qualifications, performing adjustments and repairs on packaging and pneumatic equipment, and managing machine changeovers and troubleshooting. Ensuring compliance with company policies, cGMPs, and ethical practices, along with accurate documentation, is crucial. The role includes training and guiding packaging operators/supervisors on safe and effective machine operation, breakdown, and cleaning, and adhering to all safety rules and procedures.

Requirements

Strong understanding of Packaging design principles.
Experience in Pharmaceutical manufacturing facility.
Excellent written and communication skills.
Ability to work in a team environment with multiple departments.
Knowledge and experience in troubleshooting mechanical, electrical, pneumatic, and hydraulic issues.
Can accommodate non-routine work schedules, and be able to respond to call-ins.
Self-motivated and team-oriented with the ability to work with minimal supervision and limited direction.
Mechanical aptitude, math, and computer skills.
Experience in troubleshooting equipment in the pharmaceutical industry.
Understands and is knowledgeable of cGMP, OSHA standards etc and experience in completing GMP documentation.
At least an Bachelor’s degree or equivalent in Engineering or pharmaceutical sciences or equivalent discipline.
5+ years in packaging area required including maintenance and troubleshooting.
Minimum of five (5) year work experience in nutritional’s, supplements, food, or pharmaceutical manufacturing industries.

Responsibilities

Work with R&D and customers for their packaging configurations, what motivates consumer choices, and how to optimize designs for effectiveness and sustainability, covering aspects from shelf performance to consumer convenience and environmental impact.
Ensure that packaging meets all relevant legal requirements, including labeling, safety standards, and environmental regulations.
Lead research activities for effective packaging configurations to find cost-effective solutions without compromising product quality or safety.
Communicate with suppliers of packaging materials to get all necessary information for FDA filings (i.e. DMF letters, LOAs, technical data sheets, COC/COA, test results, etc.).
Lead experimental, scale-up, exhibit batches & product launch activities with new or existing products.
Improve inefficient packaging processes to provide sustainable and environmentally compliant packaging solutions.
Assist on existing and new equipment modifications/ installations and qualifications.
Perform moderate to complex adjustments and repairs to packaging and pneumatic equipment.
Perform the changeover and set-up of packaging machines as well as troubleshoot mechanical and electrical PLC systems.
Ensure full compliance with Company policies, procedures, cGMP’s, Ethical Business Practice, and SOPs always.
Ensure documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements.
Guide and coach Packaging Operators/ Supervisors in the safe and effective operation of packaging line machines.
Training to assist with breakdown and cleaning /sanitization of the machine parts and components.
Follows all safety rules and procedures and observes the operations to ensure a safe environment.
Perform other job-related duties as assigned at the discretion of management.