Engineering - Bio Process Associate - 1st Shift100% onsite Work Schedule: Shift rotation: 3 days on (Sat, Sun, Mon), 2 days off (Tues, Wed), 2 days on (Thurs, Fri), 3 days off (Sat to Mon). Required to work on holidays and weekends as scheduledKey Responsibilities:Works on routine manufacturing assignments per written procedures that are complex with on instructions, where ability to recognize deviation from accepted practice is requiredAdheres to Good Manufacturing Practices and standard operating proceduresWeighs and checks raw materialsAssembles, cleans and sterilizes process equipment, monitors processesCompletes electronic work instructions and maintains clean room environment to comply with regulatory requirementsOperates all production equipment within the assigned functional area (i.e. Upstream: Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipments or Downstream: Buffer equipment, glass washers, chromatography skids, membrane operations, column packing skids, etc.)Effectively uses process automation systems (i.e.
Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.)Ensures less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and electronic work instructionsAssists with the coordination and implementation of special projects such as validation or complex investigationsRevises and creates process documents with no instructions, supports routine process investigationsAssists with reviewing batch and exception reports for each manufacturing lot in conjunction with Quality representativeChampions areas specific initiatives associated with work safetyEngages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environmentQualifications & Experience: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 requiredA minimum of 1 + years process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulationsStrong knowledge of either upstream and/or downstream unit operation is essentialPractical 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 expectedDemonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applicationsPrevious work experience where attention to detail and personal accountability were critical to successDemonstrates good interpersonal skills, is attentive and approachableMaintains a professional and productive relationship with area management and co-workersAdditional Job Requirements: - Lab w/o blood & animal Position Handles Hazardous MaterialsEEO: "Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."