Nashville, TN, USA
- 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.
- BS or BA or equivalent in a biological, chemical science, engineering, or degree in another discipline
- One year or more of pharmaceutical experience preferred. In lieu of degree, candidates with sufficient technical depth achieved from a minimum of three years of professional experience in an aseptic manufacturing environment may be considered.
- 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.
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