RMF Production Technician

RMF Production Technician

Requirements

• HS diploma or GED and 2+ years in cGMP or pharmaceutical or warehouse experience, military experience considered
• Associates with 1+ years in cGMP or pharmaceutical or warehouse experience, military experience considered
• Bachelors with 0+ years in cGMP or pharmaceutical or warehouse experience

Responsibilities

• Support the commissioning, set-up, testing, and qualification of new and existing manufacturing equipment.
• Support implementation of Manufacturing Executions System (MES) to optimize control of process management and execution, systems and equipment management, electronic documentation systems, and data historian.
• Assist in development of electronic logbooks (eLogbooks) and electronic BRs (eBRs).
• Setup, cleaning, and preparation of the manufacturing space to begin the performance of engineering production runs, and lead to process qualification runs and cGMP commercial production.
• Participate in execution of Environmental Monitoring Performance Qualification.
• Work collaboratively with engineering, validation, quality assurance, quality control, and manufacturing technology groups as well as external stakeholders to accomplish business needs.
• Testing of single-use bags and components.
• Proactive anticipation and effective communication of successes, constraints, conflicts, solutions, and actions for resolution.
• Follows all procedures put into effect to ensure your safety as well as the safety of others. Reports all safety issues, concerns, incidents, and near misses to the team leadership. Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions.
• Follows effective procedures to ensure the production of a safe and efficacious product.
• Participates or leads in all aspects of production process (SAP, LIMS, ordering, Labwatch, Documentum, Metasys, DeltaV etc.). Understands next steps and works to guide others through the process to complete them.
• Understands science behind process steps and technology.
• Completes tasks and corresponding documentation as required by cGMP.
• Works to become trained in all assigned training modules. Training coordinator / Trainer – Train and guide Personnel in proper work procedures, use of equipment, cGMP’s, safe work techniques and SAP to assure timely signoffs and consistency in training. Maintains qualified trainer status.
• This may require input data into SAP, along with entering work orders and reagent orders.
• Recommends changes to BRs, SOPS, and SWIs when warranted. Write and edit documents under supervision.
• Seeks out cross-training in other areas whenever possible.
• Responsible for assisting in writing and assisting incident investigations, CAPA’s, change controls, along with assisting the higher-tech levels and Principal Investigators with projects.
• Actively communicates improvement ideas, issues, concerns, etc to team members.
• Participates in cross-functional teams where necessary to complete projects in an effective and timely manner.

Preferred Qualifications

• Prior or related cGMP, Pharmaceutical, or other industrial quality management experience
• Proficiency in any of the following areas preferred: Batch record review, environmental monitoring, logbook review, technical writing, SAP, PI historian.
• Requires good mechanical skills, computer skills and is detail-oriented. Must have basic mechanical aptitude, good comprehension skills, retention skills, troubleshooting, and manual dexterity.