Operator II, Manufacturing

Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

Essential Functions

• Complete production and quality analysis of reagents, components, and finished products in accordance with SOPs, work instructions, and the Production Schedule to ensure timely availability of cost-effective products of high quality.
• Effectively communicate and interface with workgroups to ensure the completion of daily production.
• Work in both standard and cleanroom environments while adhering to room-specific PPE requirements.
• Operates and/or monitors production equipment and makes necessary adjustments to ensure smooth operations and high-quality results if required in the work area.
• Works alone or with other technicians to perform formulating, filling, and/or labeling of products
• Must be able to comprehend production paperwork up to and including product reconciliation, label reconciliation, labor sheets, product fill checks, torque checks, etc.
• Must be able to follow steps in the manufacturing paperwork without deviating from instructions.
• Must be able to work safely with chemicals and hazardous materials.
• Comply with all company safety regulations and procedures.
• Comply with ISO 13485 guidelines and all company SOPs
• Cleans and sanitizes work areas, machines, glassware, or equipment as needed or directed, if required in the work area.
• Must be able to work overtime and flexible shifts.
• Performs other duties as assigned

Position Description: Responsible for final formulation of various product lines that serve the Biotech industry. Employees carry out production processes by closely following Standard Operating Procedures and various Work Instruction Documents. Job encounters recurring work situations with occasional variations from the norm, involving a moderate degree of complexity. Accuracy is required in performing all functions of this position as mistakes in work could cause substantial interpretive errors.

 Physical Requirements

•     Ability to perform the duties of this job by regularly being required to stand; walk; use hands to finger, handle or feel objects, tools, or controls; talk and hear; and smell.

•     Ability to frequently reach with hands and arms and stoop, kneel, crouch, or crawl.

•     Ability to sit for an extended period of time depending on the nature of the work.

•     Ability to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 40 pounds.

•     Vision abilities required by this job include close vision, distance vision, color vision and the ability to adjust focus.

•     Ability to work in a moderate noise level.

Skills

• Demonstrated proficiency in the use of basic packaging techniques, equipment, and protocol record retention.
• Comfortable handling chemicals.
• Good computational skills.
• Demonstrated ability to carry out instructions without deviating.

Education

• Minimum High School Diploma or equivalent.
• BS (or AS + relevant experience) in Biology, Chemistry, Biochemistry, Molecular Biology, or other related life science discipline preferred.

Experience

• Proven ability to follow policies and procedures, instructions, and to adhere consistently and independently to the production schedule.

• Ability to work in a fast-paced environment with changing priorities.
• Basic computer skills such as proficiency with Microsoft Office Suite to support the operation in its daily functions.
• +1 year experience in a life science/biotechnology discipline preferred.
• Experience with collecting optical density measurements.
• Experience with a precise formulation of bulk reagents.
• Experience with filling, capping, and labeling using precision liquid handling tools and processes.
• Experience in manufacturing diagnostic products for research and regulated markets.
• Experience in completing documentation using GDP (Good Documentation Practices)