Role Summary
Position: Packaging Technician II. The successful candidate will operate and maintain packaging equipment, ensure compliance with cGMP and safety standards, and support the efficient flow of materials throughout the production process. This hands-on role includes equipment setup and cleaning, accurate documentation, and adherence to standard operating procedures. The ideal candidate will have strong mechanical aptitude, a commitment to quality, and the ability to work both independently and collaboratively in a fast-paced environment.
Responsibilities
- Record Keeping and Documentation
- Maintain and complete accurate records (timecards, batch records, logbooks, etc.) in accordance with cGMP and GDP requirements.
- Equipment
- Operate assigned equipment, i.e. PLC controlled packaging line, vision system, etc.
- Clean production equipment and facilities.
- Set-up/disassemble packaging equipment.
- Operate specific in-process devices associated with the equipment.
- Operate material handling devices, electric pallet jack, manual pallet jacks, and hi-lifts.
- Apply the metric system to assigned process calculations.
- Conduct visual inspections.
- Conduct detailed troubleshooting and advanced maintenance of packaging equipment
- Monitor and check line operations to ensure all packaging procedures are being accurately completed for each product
- SOPs / cGMPs
- Follow all SOPs/cGMPs applicable to the area.
- Review and update SOP's and Operational manuals
- Apply proper housekeeping techniques.
- Follow proper dress and secondary gowning policy.
- Conduct employee training
- Safety
- Practice good safety techniques in the manufacturing area., including lock-out/Tag-out procedures.
- Read and interpret Material Safety Data Sheets (MSDSs).
- Properly use Personal Protective Equipment (PPE) as required per SOPs, i.e. safety shoes, safety glasses, respirators, gloves, hearing protection, etc.
- Decision Making -- Demonstrated ability to:
- Delegate questionable issues upward.
- Follow directions either written, or oral.
- Know when to stop the process for anomalies.
- Learn to identify "out-of-spec" material.
- Process
- Familiar with production/ process flow.
- Know proper staging and storage location for supplies and equipment.
- Learn key terminology associated with Biological Manufacturing.
- Communications
- Communicate effectively with peers and supervisor.
- Apply appropriate communication techniques for team work.
Qualifications
- High school diploma or equivalent is required; additional technical training or certification preferred.
- 2-5 years of relevant experience in a manufacturing environment required, or pharmaceutical or biological industry background preferred
- Demonstrated technical understanding of packaging equipment
- Basic understanding of mechanical skills and experience with use of various hand tools
- Knowledge of GMPs, SOPs, and regulatory requirements.
- Strong attention to detail and ability to maintain accurate records.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Willingness to participate in overtime rotation and handle emergency situations.
- Experience with vision systems and robotic fillers preferred.
- Able to navigate the basics of Microsoft Applications (Excel, Word, SharePoint, Outlook, SAP) is preferred.
Physical Requirements
The physical requirements described here are representative of those that must be met by an employee to successfully perform the principle duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the principle duties.
- Apply good lifting techniques.
- Prolonged periods of standing
- Will be exposed to routine lifting of 20-40 lbs., and occasionally lift up to 50 lbs.
- Ability to work flexible hours and overtime.
- Ability to move up and down stairs/ladders.
Work Environment
- Exposure to cleaning chemicals.
- Exposure to product dust/particulate
- Exposure to loud noise.
- Exposure to temperature variations.
- Exposure to moving mechanical parts