Pharma Manufacturing Technician 1

About the Role

Responsible for collaborating and working in a team environment of 12-30 manufacturing production technicians. Performing operations with focus on efficiency, training, and project work to accomplish manufacturing objectives. This position supports the North American Nuclear Medicine Business consisting of 30+ nuclear pharmacies and numerous direct hospital customers. The Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams.

Key Responsibilities

• Process, assemble, dispense, assay and package radio chemicals, radiopharmaceuticals or radioactive devices in accordance with established procedures.
• Knowledge of all preparations and manufacturing procedures for the formulation of final product.
• Assists in training and development of other technicians.
• Accurately review and complete all batch records and related documentation.
• Preparation and set-up of associated equipment and materials.
• Comply with all applicable Environmental Health & Safety (EHS), Health Physics, Quality System Requirements (QSR’s) and Personal Protective Equipment (PPE) requirements.
• Strict adherence to cGMP at all times.
• Perform housekeeping in accordance with 5S policy perform Preventative Maintenance (PM) as required.
• Troubleshoot basic equipment problems by communicating with the Lead Technician.
• Assist in writing Deviations, Investigation and initiate Unscheduled Work Orders (UWOs).
• Utilize Quality Management System to document maintenance, investigations, and change control actions.
• Utilize Electronic Document Management System to manage web-controlled documents.
• Ability to pass all gown qualifications is required for employees who need to perform work in the controlled manufacturing areas.
• The manufacturing line will require operators to be on their feet for part of the shift to perform the required operations.

Requirements & Tech Stack

• Associate’s degree plus a minimum of 1 year's experience in areas such as pharmaceutical manufacturing, equipment operator, material handling, food processing, warehousing, or logistics/distribution.
• OR High School diploma/GED equivalent plus a minimum of 2 years' experience in areas such as pharmaceutical manufacturing, equipment operator, material handling, food processing, warehousing, or logistics/distribution.
• OR Bachelor's Degree - No Manufacturing Experience Required.
• Strong computer skills with ability to learn new applications.
• Strong mathematical aptitude including Algebra.
• Strong Communication skills.
• Must perform shift/weekend work (shift differential will apply).
• Must be able to lift 35 lbs. or more.
• Legal authorization to work in the U.S. is required.

Qualifications (Preferred)

• Bachelor's degree plus 2 years' experience working in a cGMP manufacturing environment.
• Experience with manufacturing equipment.
• Previous experience in roles requiring strong attention to detail.
• Experience working with HPLCs (High-Performance Liquid Chromatography) in a Manufacturing or Laboratory setting is a plus.
• Experience performing necessary preventative maintenance on HPLCs is a plus.
• Strong technical writing ability.
• Ability to multi-task.
• Experience working with radioactive materials and/or radioactive isotopes is a plus.
• Experience working with SAP, Trackwise, Veeva, and ComplianceWire is a plus.