Biologics Process Operator

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This role is a TEMP TO HIRE, after 6 months-- based on performance. Please ensure you are submitting candidates interested in full time. DOWNSTREAM Purification 5 am to 5 pm 2 week rotation. DAYS: 3 on 2 off, then 2 on 3 off, 2 on 2 off. FTE package includes:
Medical, pharmacy, dental and vision benefits, Vacation/holiday, Retirement savings plan, Disability, life and business travel accident insurance, Financial Tools and Assistance.

B22 – Biologics Senior Process Operator

• Works on routine manufacturing assignments per written procedures, that are moderately complex with minimal instructions, were ability to recognize deviation from accepted practice is required.
• Adheres to Good Manufacturing Practices and standard operating procedures.
• Weighs and checks raw materials, assembles cleans and sterilizes process equipment, monitors processes.
• Completes electronic work instructions and maintains cleanroom environment to comply with regulatory requirements.
• Operates primary production equipment within the assigned functional area (i.e. bioreactors, chromatography skids, media or buffer preparation equipment, etc.), as instructed.
• Effectively uses in process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and other supporting business systems (i.e. Maximo, SAP, Track Wise, etc.) to maintain production records.
• Revises and creates process documents with little to no instruction, assists with process-related investigations.
• Leads in maintaining material and component inventory levels.
• Assists with reviewing batch and exception reports associated with each manufacturing lot, in conjunction with supervisor and Quality representative.
• Provides assistance for area-specific initiatives associated with a safe work environment.

Knowledge:
High School diploma is required. Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is desired but not required. A minimum of 2+ years of process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations. Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP).

Prior evidence of successful participation on work/study teams where combined contribution, collaboration, and results were expected. Demonstrated proficiency in common computer tools such as word processing, spreadsheets, and web-based applications. Work/Study experience where attention to detail and personal accountability were critical to success. Demonstrates good interpersonal skills, is attentive and approachable, and maintains a professional and productive relationship with area management and co-workers.

Contacts:
Senior Bioprocess Operators will work in teams and have continual interaction with members of their teams as well as other bioprocess teams throughout the manufacturing process in order to exchange information regarding the batch(s) in process. In addition, there will be frequent contact with the quality department regarding in-line sampling and variance investigation. Lesser but also important are interactions with Materials Management and Maintenance staff for supplies and repair of equipment.

All Bioprocess Associates/Specialists will have daily contact with their supervisory staff for work assignments, coaching, and general management discussions. Occasional contact with other line management staff relating to specific project responsibilities may be expected.

Working Conditions:

Work is performed in a state-of-the-art large‑scale cell culture facility with classified areas requiring appropriate personal protective equipment (PPE). These roles require some contact with hazardous materials such as caustic and steam.