Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift

Job Description

Summary:

Be a Lead Process Technician at Thermo Fisher Scientific Inc., ensuring flawless operations and promoting collaboration in a dynamic setting.

Essential Functions:

Ensure day-to-day manufacturing operations and activities are completed safely, compliantly, and in accordance with all applicable regulatory agency (e.g., FDA, OSHA) requirements and Company policies and procedures.

Direct the workforce to meet production goals and process requirements. Schedule, control, and prioritize daily work assignments. Manage day-to-day workflow for a team of up to 8 Process Technicians.Resolve emergent issues, including troubleshooting process, equipment, and system malfunctions or failures on a 24-hour/7-day basis.Provide feedback to the Supervisor on work-related issues and employee performance appraisals.Ensure housekeeping and Asset Life Cycle Management responsibilities are maintained in assigned areas.Initiate and approve work orders when needed. Schedule maintenance activities around the production schedule to ensure cost-effectiveness.Write, develop, implement, and train employees on department SOPs.Suggest continuous improvement activities within LSM operations and assist with implementation.Enter Incident Reports, variance, and associated CAPAs.When needed, complete assigned CAPAs, start discrepancies, and aid in subsequent investigations.Coordinate, record, and uphold the Company’s Quality Systems conformity to regulations and company policies as needed using the Company’s Quality System tools and direct actions.

Education:

High school diploma or equivalent experience

Experience:

Minimum of 3-5 years’ Process Technician experience working in the pharmaceutical industry.Successful completion of Phases I-IV of the Process Tech On-The-Job Training Program/process involving learning/applying Chemical Technology, Math, and Chemistry.Strong mechanical competence.

Equivalency:

Proficiencies: Good understanding of basic equipment. Strong problem-solving skills and logical approach to problem-solving. Demonstrated interpersonal and communication skills for team collaboration. Capability to interpret technical procedures and governmental regulations. Proficiency in applying basic mathematical principles.

Physical Requirements:

Employee must frequently stand, use hands, reach, sit, talk, walk, stoop, kneel, crouch, climb stairs, lift up to 50 lbs., and sit for up to 4 hours. Vision abilities include close vision and focus adjustment.

Disclaimer Statement: “The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.”