Senior Bioprocess Associate

Work on routine manufacturing assignments per written procedures that are moderately complex with minimal instructions, here ability to recognize deviation from accepted practice is required. Adheres to GMPs and standard operation procedures. Weighs and checks raw materials. Assembles, cleans and sterilizes process equipment, monitors processes. Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements. Operates primary production equipment within the assigned functional area (i.e. chromatography skids, buffers preparation equipment etc.) as instructed. Effectively uses in process automation system (i.e. Delta-V and Syncade Interactions. Pi Historian) and some supporting business systems (i.e. SAP, Trackwise, Maximo 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 components inventory level. Assists with reviewing batch and exception reports associated with each manufacturing lot, in conjunction with supervisor and Quality representative. Provide assistance for areas specific
initiatives associated with work safety.
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.
A minimum of 2+ years of process operations experience in a highly automated biotechnology manufacturing facility subject to GMP regulations. Practical knowledge of regulations such as GMP and company standard operating procedures (SOP). Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected. Demonstrated proficiency in common computer tools such as work processing, spreadsheet and web based applications. Previous work experience where attention to detail and personal accountability were critical to success. Demonstrates good interpersonal skills, is attentive and approachable. Maintains a professional and productive relationship with area management and co-workers.
Sr.Bioprocess associate will work in teams and have continual interaction with members of his/her team 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 members of the Quality department with regard to inline 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 her/his 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.
Work is performed in a state of the art large scale manufacturing facility with classified areas requiring appropriate personal protective equipment. These roles require some contact with hazardous materials such as caustic and steam.
Works on assignments that are moderately complex in nature where judgement is required in resolving problems and making routine recommendations.
The rotating shift schedule time is 0500-1700.
Excellent communication skills, adaptability, growth mindset, and team work are a must have for this position.

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