Packaging Technician

Responsibilities in a Startup Environment

In a startup environment, the Packaging Technician will adapt quickly to changes, lead in developing and optimizing new processes, and identify opportunities for innovation and improvement. This role involves close collaboration with cross-functional teams, managing inventory and resources efficiently, and troubleshooting unexpected challenges. The technician will also contribute to scaling production processes, participate in diverse tasks to support the dynamic needs of the startup, and ensure the sustainability and scalability of all procedures as the company grows. Specific activities would include FAT, SAT, CQV, media fills and engineering runs that lead to stability batches. In addition to Packaging, also being flexible and having the ability to learn aseptic processing to support startup activities.

Position 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 and use PAS-X electronic batch records
• 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 Packaging/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

• 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

Personal Computer Skills

• Perform PC tasks

Qualifications

• High school diploma or equivalent is required; additional technical training or certification preferred
• 2-5 years of relevant experience in a Packaging/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 pick and place machines preferred
• Able to navigate the basics of Microsoft Applications (Excel, Word, SharePoint, Outlook, SAP) is preferred

Schedule

1st Shift: 7:00am-3:30pm

Physical Requirements

• 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