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Sr. Manufacturing Technician
The role is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. In addition to being fully accountable and involved in all production processes, he/she may problem solve in other functional areas. The incumbent acts as a delegate to the supervisor and may conduct departmental activities in their absence. He/She fully understands the regulations and may make recommendations according to their interpretations. He/She is responsible for the successful transfer of new processes/methodologies into the manufacturing area.
• Assist supervisor in organizing, scheduling and directing other team members.
• Main interface with other departments to resolve issues related to equipment, process, compliance, including maintenance, metrology, and validation.
• Involved in hands-on execution of manufacturing operations.
• Ensure timely and accurate generation of process documentation. Review documentation.
• Resolve issues related to equipment, process and compliance. Main troubleshooting/response person.
• Investigate any process problems timely and provide documentation.
• Participate on Continuous Improvement Teams and may serve in a leadership role.
• Train and mentor other team members and monitor training for newer team members.
• Assist with process/equipment validation and data analysis
• Assign other project work and/or involvement in teams to team members.
• Represent the department in cross functional teams as necessary.
• May perform other duties as assigned.
Education and Experience Requirements
• Typically requires a high school diploma or GED plus 4+ years of related work experience or associates’ degree or higher and 2+ years related work experience.
Key Skills, Abilities, and Competencies
• Knowledge of cGMP manufacturing and in-depth process knowledge of related manufacturing techniques/specialties.
• Thorough knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.
• Must be able to apply quantitative analysis to analyze process performance.
• Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
• Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Good procedural writing skills.
• Knowledge of chemical and biological safety procedures.
• Good computer skills, knowledge of Microsoft Word and Excel.
• Must have demonstrated interpersonal and leadership skills and be able to lead a work team effectively and efficiently in a team environment.
Other Job Requirements
• Must be able to carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
• Must be able to stand for extended periods of time over an entire 8 or 12-hour shift.
• Must be able to climb ladders and stairs while wearing special gowning.
• May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will work in a cold, wet environment.
• Must be able to work multiple shifts, including weekends. Must be able to work overtime as required.
• May be required to work in a confined area.
• Some Clean Room and cool/hot storage conditions.
• May require immunization before performing work within the manufacturing area.
This posting excludes CO applicants.