Biotech and Pharmaceutical, Coaching, Continuous Improvement, Current Good Manufacturing Practice (cGMP), Documentation, Energy Efficiency, FDA (Food and Drug Administration), High School Diploma, Identify Issues, Inventory Transactions, Lift/Move 30 Pounds, Maintain Compliance, Manufacturing, Mentoring, Onboarding, Operational Improvement, Operational Strategy, Operations Processes, Organizational Skills, Pallet Jack, Physical Demands, Problem Solving Skills, Process Development, Process Improvement, Production Systems, SAP, Safety Training, Safety/Work Safety, Standard Operating Procedures (SOP), Startup, Technical Leadership
Job Title: Packaging Operator III Department: Packaging
Reports to: Packaging Supervisor Effective Date: TBD
Position Summary
The Packaging Operator III serves as an advanced operator and subject matter expert within Packaging Operations. This position performs complex packaging activities, provides technical guidance to team members, supports equipment troubleshooting and process improvements, and serves as a key resource for production efficiency, quality, and compliance.
Essential Duties and Responsibilities
- Perform all duties of Packaging Operator I and II.
- Independently operate a minimum of three packaging lines OR 2 lines plus Wonderware CIP qualification or meet alternative qualification requirements established by management.
- Serve as a subject matter expert for packaging equipment, processes, and department SOPs.
- Lead troubleshooting efforts for equipment and process issues.
- Assist with maintenance activities and equipment assessments as needed.
- Participate in SOP reviews, revisions, and process improvement initiatives.
- Review production processes and recommend operational improvements.
- Support line changeovers, startup activities, and production readiness reviews.
- Assist supervisors and leads in ensuring compliance with FDA, cGMP, GDP, and safety requirements.
- Provide technical guidance and coaching to Material Handlers, Packaging Operator I, and Packaging Operator II employees.
- Assist with training, qualification, and onboarding activities.
- Operate electric pallet jacks and other approved equipment.
- Perform additional duties as assigned.
Qualifications
Education
- High School Diploma or GED required.
- Technical, vocational, or manufacturing certifications preferred.
Experience
- Minimum 6-9 months as a qualified Packaging Operator II or equivalent advanced packaging experience.
Knowledge, Skills and Abilities
- Advanced knowledge of FDA, cGMP, GDP, and pharmaceutical packaging requirements.
- Expert understanding of packaging equipment, processes, and documentation requirements.
- Advanced mechanical aptitude and troubleshooting capability.
- Strong knowledge of SAP inventory transactions and production systems.
- Ability to identify process improvements and drive operational efficiencies.
- Ability to mentor and develop less experienced operators.
- Strong technical leadership, communication, and organizational skills.
- Serves as a subject matter expert and technical resource for packaging operations.
- Demonstrated ability to work independently with minimal supervision.
Physical Requirements
- Frequently stand, walk, bend, reach, and lift up to 30 pounds.
- Ability to wear required PPE for extended periods.
- Ability to work in a manufacturing environment with varying temperatures and noise levels.
Performance Expectations
To maintain Packaging Operator III status, employees must:
- Demonstrate mastery of Packaging Operator I and II responsibilities.
- Independently operate at least three qualified packaging lines.
- Serve as a technical resource and subject matter expert.
- Demonstrate advanced troubleshooting and problem-solving skills.
- Participate in SOP reviews and continuous improvement efforts.
- Provide coaching and guidance to other operators.
- Maintain exemplary safety, quality, and compliance performance.
To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify.
PAI Pharma is a nicotine-free campus, meaning the use of nicotine products-including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances-is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.
EEO Employer / Veteran / Disabled