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Associate Principal Bioprocess Automation Engineer - cGMP

• Define, deploy, implement, start-up, and qualify process platform equipment and automation solutions across Cell Therapy, mAb, rFVIII, and other biologics modalities;
• Act as a recognized internal Automation SME and technical authority for equipment platforms, covering installed systems and emerging market technologies;
• Lead hands-on automation project delivery across all phases (feasibility, concept, detailed design, implementation, start-up, qualification);
• Responsible as technical system owner for automation packages, control systems, and user interfaces, translating user requirements into compliant technical solutions;
• Directly support the realization of automation for Bayer’s next-generation Cell Therapy manufacturing platforms and facilities;
• Drive continuity and standardization of automation technologies across the Biotech / Product Supply network while supporting site-based execution;
• Support the implementation and integration of Manufacturing Execution Systems (MES) in new and existing GMP facilities;
• Lead mid-size projects and provide functional leadership and technical guidance to engineers and cross-functional teams;
• Represent Bayer Automation as technical authority in collaboration with external vendors, OEMs, partners, and acquired assets;
• Ensure compliance with GMP, CSV, 21 CFR Part 11, and internal engineering standards and good engineering practices.

• Must have one of the following:
• Minimum of a Bachelor’s Degree and 8+ years of relevant experience within Biopharma industry; OR
• Minimum of a Master’s Degree and 6+ years of relevant experience within Biopharma industry; OR
• PhD and 4+ of relevant experience within Biopharma industry;
• Extensive experience in the Automation industry with experience in Design, Construction, and Commissioning;
• Significant and relevant experience with capital projects;
• Extensive amount of experience with standard industrial automation technologies, DCSs, PLCs, SCADAs, and HMI programming;
• Strong knowledge of control system philosophy, control system standards, instrumentation configuration, programming, and design in a cGMP environment;
• Strong knowledge of Industrial networks including Ethernet networks, Profibus and OPC communication;
• Strong working experience in working with ISA 88 and ISA 95 levels;
• Technical expert in DeltaV DCS.

• Professional registration and/or certifications as appropriate;
• 12+ years of experience in the Automation industry with experience in Design, Construction, and Commissioning;
• 8+ Years of relevant experience in capital projects;
• 12+ Years of experience with standard industrial automation technologies, DCSs, PLCs, SCADAs, and HMI programming;

• Entrepreneurial mindset;
• Mastery of English language, written and oral;
• Good analytical and problem solving (decision making) skills;
• Collaborative team player capable of working well with people across all hierarchies;
• Good organizational and presentation skills;
• Good interpersonal skills such as communication, listening, verbal and assertiveness;
• Must be able to work independently with minimal supervision, multi-task and support several projects simultaneously;
• Result driven and able to deal with ambiguity;
• Ability to work in different geographic locations;
• Willingness to execute projects at remote locations with up to 25% travel.