Clinical Supply Operations Packaging Technician

What You Will Achieve

You must maintain daily compliance to Standard Operating Procedures (SOPs), in accordance with current Good Manufacturing Practice (cGMP) guidelines and be responsible for performing operations to support the packaging and labelling of clinical trial supplies. Your role performs both Primary Packaging and Secondary Packaging Operations. This may include (but is not limited to): solid dose drug product by way of manual hand count filling into bottles or by use of minor equipment for automated filling, packaging finished dosage forms such as filled bottles, ointments, pre-filled vials and labelling of other pre-packaged finished material. This position is also responsible to maintain the packaging equipment for daily use including cleaning.

How You Will Achieve It

• Responsible for performing primary and secondary operations in a GMP environment, executing operations following instructions on the approved packaging batch records in accordance with cGMPs and safety regulations.
• Responsible for completing required GMP documentation to ensure records of equipment used and packaging activities performed are maintained contemporaneously in applicable documentation
• Responsible for adhering to SOPs, cGMPs, and all safety requirements involving handling and movement of clinical trial materials
• Responsible for using EMD365 to scan material and perform tasks required for packaging operations
• Responsible for supporting routine daily, weekly, monthly, and quarterly maintenance, inspection and cleaning of the rooms and equipment in the GMP packaging areas as directed.
• Follow and adhere to production schedules and timelines.
• Support and assist resolution of common equipment/process failures.
• Responsible for attending required meetings as necessary for business updates.
• Utilize AI platforms in job responsibilities where applicable.

Qualifications

Must Have's

• High School Diploma or equivalent
• 4+ years of relevant experience.
• Excellent documentation skills and attention to detail.
• Computer literacy in Microsoft Word.
• Strong computer, scientific, and organizational skills.
• Excellent communication (oral and written) and attention to detail.
• Ability to work as part of a team, self-motivated, adaptability, and a positive attitude.
• Ability to learn new techniques, keep accurate records, follow instructions, and comply with company policies.

Nice To Have's

• Understanding of Good Manufacturing Processes (cGMP), experience preferred.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Physical Requirements and Work Environment

Adherence to regulations and rules such as necessary gowning requirements to gain entry and perform daily operations in the packaging areas are required. Regular gowning requirements include: bouffant head covering, face mask, gloves, shoe coverings, safety glasses/goggles. No make-up, nail polish, and/or jewelry may be worn in the packaging areas where daily operations are performed. The incumbent is subject to standing for sustained periods of time as well as walking, pushing, pulling and lifting of equipment and/or materials weighing up to a maximum of 45 pounds. Continuous mental and visual attention as well as manual dexterity to perform packaging and labelling functions is required.