Pharmaceutical Packaging Development Engineer

Granules Pharmaceuticals Inc.; Manassas (VA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Granules Pharmaceuticals Inc. in Manassas, VA is seeking an experienced Packaging Engineer to lead pharmaceutical packaging initiatives across R&D, manufacturing, and quality.

You will optimize configurations for performance, cost, and sustainability while ensuring regulatory compliance. You will supervise packaging line operations, coordinate with suppliers for FDA filings, and drive equipment changes, calibrations, and qualifications.

Qualifications

• Bachelor’s degree in Engineering or pharmaceutical sciences.
• 5+ years in packaging including maintenance and troubleshooting.
• Experience in nutritional, supplements, food, or pharmaceutical manufacturing.
• Strong written and verbal communication.
• Ability to work with multiple departments in a team.
• Knowledge of cGMP, OSHA and GMP documentation.

Responsibilities

• Lead packaging configurations with R&D and customers for efficiency and sustainability.
• Ensure packaging meets labeling, safety, and environmental regulations.
• Coordinate with suppliers for FDA filings and technical data.
• Oversee equipment modifications, modifications and qualifications.
• Perform changeovers and set-up of packaging machines; troubleshoot PLC systems.
• Coach operators and supervisors on safe operation and cleaning.
• Maintain logs and batch records in compliance with SOPs.

Skills

Packaging design principles

Pharmaceutical manufacturing

GMP documentation

Troubleshooting packaging equipment

cGMP/OSHA knowledge

Team leadership

Written and verbal communication

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or pharmaceutical sciences

Job description

Description

Areas of Responsibility include but not limited to:

• 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. This includes 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.

Requirements

Minimum Knowledge/ Skills

• 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.

Minimum Experience & Education

• 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.