Manufacturing Technician I/II/III – Filling, Lyophilization, & Terminal Sterilization 1st & 2nd Shift - August Bioservices

Responsibilities

• Operate processing equipment in accordance with SOPs, in classified areas.
• Actively participate in troubleshooting processes and equipment problems as well as assisting the manager in completing all necessary paperwork associated with investigations, deviations, and remarks.
• Use proper aseptic technique while performing tasks to set up filling line equipment including; vial / syringe fillers, lyophilizer loading system, capper and tray loader, parts / terminal sterilizers
• Perform manipulations via glove ports in the filling isolator (ISO 5) to include: set up of filling line, routine aseptic interventions (pulling of samples, EM monitoring & clearing downed vials / syringes), non-routine aseptic interventions (filler setup, needle changeout), operating filling and auto loading equipment using automated control systems; perform automatic weight checks; assist with and performs all interventions without compromising aseptic environment.
• Break down of filling line equipment for changeovers, clean and sanitize, set up RABS for next fill
• Actively participate in the completion of batch records, protocols, and all other GMP documents, following Good Documentation Practices (GDP).
• Troubleshoot process equipment and interact with maintenance personnel.
• Demonstrate proficiency as outlined in training requirements for equipment systems and position.
• Responsible for loading and unloading materials, labeling according to SOPs, assembling valves, connectors, and other equipment and tools using Aseptic technique.
• Recognize and report deviations or potential issues immediately to the management team.
• Perform manual packing.
• Communicate and report status of equipment maintenance related issues to the area supervisor / manager and assist with actions necessary to resolve issues.
• Perform all job responsibilities in compliance with applicable EHS, GMP, SOP regulations, guidelines, and policies.
• All manufacturing team members are expected to support all production areas as needed for material movement/transfers, gowning and production supplies and cleaning/sanitization of all production areas.

Requirements

• HS Diploma Required
• One year or more of pharmaceutical, manufacturing, or other production experience preferred.
• Mechanical aptitude required to operate pumps, tanks, filling equipment, lyophilization equipment, and terminal sterilizing equipment.
• Attention to detail and quality and a high level of integrity and confidentiality while completing multiple or repetitive tasks and meeting timelines and deadlines.
• Ability to read, understand, follow, and comply with technical and written documents (SOPs.)
• Ability to work around acids, bases, oxidizers and cleaning solvents while wearing appropriate PPE.
• Ability to perform calculations using simple mathematical formulas using fractions, percentages, and significant numbers. The ability to accurately measure volume and weight.
• Must be able to follow detailed processing instructions as well as clearly and accurately documenting all necessary batch documentation.
• Basic computer skills required.
• Ability to complete and maintain gowning requirements. Must be able to work while wearing full protective gowning required for GMP areas for an entire shift.
• Physical requirements include stooping, standing, climbing, and lifting between 30 - 50 lbs.
• Ability to establish and maintain working relationships cross functionally including production, QA, QC, engineering, validation, and maintenance.
• The ability to communicate effectively, both verbally and in writing, to all levels within the organization.
• Position may require employees to work in a 24/7 rotational schedule. This schedule will include holidays, and weekends; over-time may be required. Work closely with shift team to achieve goals in a 24/7 cGMP Production Environment.

PI250509244