Pharmaceutical Packaging Development Engineer

ISPE International; Manassas (VA); On-site; USD 85,000 - 120,000; Full time

Job summary

ISPE International is seeking a Packaging Engineer with a strong background in pharmaceutical packaging. The role focuses on designing and optimizing packaging configurations to improve shelf performance, consumer convenience, and sustainability.

The candidate will ensure labels, safety, and environmental compliance, lead scale-up activities, coordinate with suppliers for FDA filings, and drive GMP documentation across manufacturing facilities.

Qualifications

• Strong understanding of packaging design principles.
• Experience in pharmaceutical manufacturing facility.
• Excellent written and communication skills.
• Team-oriented with cross-department collaboration.
• Troubleshooting mechanical, electrical, pneumatic, and hydraulic issues.
• Familiarity with cGMP and OSHA standards; GMP documentation experience.

Responsibilities

• Collaborate with R&D and customers to optimize packaging configurations for sustainability and shelf performance.
• Ensure packaging meets labeling, safety, and environmental regulations.
• Lead research for cost-effective packaging solutions without compromising quality.
• Coordinate with packaging material suppliers for FDA filings and data.
• Lead experiments, scale-up, batches, and product launches.
• Improve packaging processes for environmentally compliant solutions.
• Oversee equipment modifications, installations, and qualifications.
• Perform adjustments and repairs to packaging and pneumatic equipment.
• Handle changeovers and setup of packaging machines; troubleshoot PLC systems.
• Ensure compliance with company policies, cGMP, SOPs; maintain logs and batch records.
• Coach packaging operators/supervisors on safe operation and sanitation.
• Adhere to safety rules and observe operations.
• Perform other duties as assigned.

Skills

Packaging design principles

Pharmaceutical manufacturing knowledge

Troubleshooting (mechanical/electrical

Team collaboration

Documentation (logs/batch records)

Education

Bachelor’s degree in Engineering or Pharmaceutical Sciences

Job 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.

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.