Manufacturing Technician I/II/III - Formulation & Component Prep 2nd Shift Only - 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; parts / terminal sterilizers, parts washing system, and other supporting component preparation systems
• Use proper technique while performing tasks to set up equipment including mixers, tanks, valves, etc.
• Actively participate in the completion of batch records, protocols, and all other GMP documents.
• Adhere to requirements for Good Documentation Practices (GDP) and cGMP requirements.
• Complete dispensing, formulation, filter integrity testing, sample submission, filling, and all other supporting processes per batch record documentation, procedures, protocols, etc.
• Break down compounding equipment for changeovers, clean and sanitize, set up
• Troubleshoot process equipment and interact with maintenance personnel.
• Demonstrate proficiency as outlined in training requirements for equipment systems and position.
• Recognize and report deviations or potential issues immediately to the management team.
• Perform manual packing.
• Ability to properly enter cleanrooms, maintain gown certification requirements, and demonstrate proper cleanroom environment behavior, including aseptic technique.
• 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 autoclaves, depyrogenation tunnels, and other component preparation equipment as well as mixers, pumps, balances, pH meters, and other formulation and compounding related 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.

PI250509228