Contract / Temp to Direct / Direct Hire: Temp to Direct
Country: United States
Operator IV / Lead Operator
•AA Degree in technical area and 4+ years relevant industry experience OR BS Degree in science or engineering and 2+ years relevant industry experience OR 5-8 years relevant industry experience as determined by management
•Detailed knowledge of the scientific principles pertaining to standard processing and manufacturing equipment including, but not limited to, isolators/glove boxes, homogenizers, extruders, pumps, stirred-reactors, lyophilizers, filtration devices, hot oil systems, cooling systems, grinding mills, pelletizers, fillers, etc.
•Excellent written, verbal, and organizational skills
•Capable of authoring and comprehending technical writing
•Ability to execute directions with or without the help of others
•Team player, safety minded
•Excellent math skills, Excellent computer skills, Excellent interpersonal skills
•Ability to lead a group of people toward common objectives
•Demonstrate excellent conflict resolution skills including verbal and clear documentation
•Clear understanding of GMP requirements and how they apply to our business
•Must be computer literate and have experience in MS Word, Excel, Trackwise
•Demonstrated problem analysis and issue resolution skills
•Ability to work in heavily regulated environment
•Able to wear required Personal Protective Equipment (PPE)
•Able to lift up to 50 lbs without assistance on a routine basis
•Able to ascend/descend stairs
•Able to work in a high noise/high temperature environment
•Able to use stairs and ladders to perform some tasks
•Able to use hand tools, for some operations and basic repairs
•Must be able to work 12 hour shifts, days or nights including holidays and weekends
•Must be flexible and willing to adjust schedule to meet business needs as operations run 365 days a year
•May be required to work overtime to support business needs
•Hazardous conditions involving the use of acids, caustics, other hazardous chemicals, and potential irritants
Job Description This position is responsible for directly contributing to, and leading, focused teams supporting pharmaceutical/polymer process development and design and/or participation in cGMP or non-cGMP manufacturing activities. This position is responsible for assisting with all aspects of aseptic / terminally sterilized / polymer (clean rooms) and/or non-aseptic (Pilot Plant) processes and procedures for pharmaceutical and/or polymer manufacturing (development/engineering, clinical-phase and/or commercial).
Primary responsibilities and accountabilities of the job are in addition to Operator I, Operator II, and Operator III job functions.
Frequency: Daily – 45% of time spent on the following
•Strict adherence to ESHS practices, rules and procedures including use of personal protective equipment (PPE) appropriate for the type of hazard and exposure potential associated with certain job tasks.
•Report all near misses or injuries to ESH and supervision within the same shift of the incident occurring.
•Conduct all development/engineering, clinical-phase and/or commercial batches in a safe manner by use of SDS to establish chemical hazards. Provide feedback and coaching to coworkers on both safe and unsafe behaviors and conditions.
•Lead safety discussions and support continuous improvement of the safety culture.
•Perform responsibilities in compliance with the quality systems as described in the Quality Manual.
•Observe appropriate cGMP/GDP procedures and adhere to all written instructions.
•Strict documentation practices are followed to ensure that all steps of the operation are appropriately documented.
•If applicable, supervision of hourly clean room suite personnel including, but not limited to, personnel work schedules (in conjunction with Production Supervisor or Manufacturing Management personnel), personnel adherence to aseptic practices (when applicable), time-sheet approvals, PTO requests, performance reviews, etc.
•Help secure shift coverage for planned and unplanned absences.
•Responsible to lead shift team during daily operations.
•Fill in for supervisor during absences as needed.
•Provide daily schedule updates to supervisor with accountability for timely completion of batches as defined in the master production schedule.
•Lead daily shift change meetings.
Frequency: Weekly – 45% of time spent on the following activites:
•Participate in planning and scheduling meetings with other departments.
•Immediate reporting of all deviations to supervision (within one calendar day).
•Enter deviations into Trackwise and drive deviation resolution within team.
•Enter change controls into Trackwise and manage to completion.
•Maintain all work areas in a state of cleanliness and sanitation by following departmental initiatives in the areas of 5s, good housekeeping practices, and good personal health practices.
•Demonstrate independent personal proficiency of aseptic conduct / technique as well as the capability to train others in proper aseptic conduct / technique practices.
•Help drive accountability in ensuring that master batch production records (MBPR) documentation is up to date at the end of each shift.
•Perform final review of MBPR before submission to document specialist.
•Drive continual improvement in shift change-over communication.
•Administer training to operators on shift (qualifications, OJT, etc.).
•Operate PLC controlled equipment, including adjusting set points as directed in batch records, without direct supervision.
•Use basic hand tools and specialty tools as required for equipment operation.
•Seek out and identify opportunities related to the maintenance, calibration, and improvement of company facilities, equipment, and procedures.
•Interact and communicate effectively with Project Managers and/or clients on technical aspects of the project.
•Provide feedback and improvement ideas to area management and technical support staff.
•Perform other duties as required by supervisor.
Frequency: Monthly – 10% of time spent on the following activities:
•Participate on process hazard assessments (PHA’s).
•Serve as coordinator with facilities for departmental maintenance and capital project activities.
•Be a representative for the department on capital project teams.
Location of Job Birmingham, AL
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