Project Engineer II

• Plan, coordinate, and execute assigned projects by effectively using Project Management methodologies (such as MS Project) from conceptual design to financial close for projects up to $5M
• Acts as the Engineering Lead for assigned projects and assembles a cross-functional team to drive the engineering activities
• Develops project scopes that include complex process designs, project plans, and project deliverables
• Identifies equipment lists and specifications with suppliers, creates engineering drawings (PFDs, P&IDs, general arrangement), and specifies facility requirements or modifications to meet the project deliverables
• Builds well defined cost estimates and timelines for the project scope
• Manages project related procurement processes from initial quoting to final invoicing
• Collaborates with Evonik Safety to execute risk and hazard analysis associated with projects and implement any mitigating safety requirements
• Performs costs analysis and review alternative project designs to implement best business solutions that optimize costs and functionality
• Coordinates and executes all required QMS processes and procedures related to engineering projects
• Communicates general project status including cost and timeline forecasts to the client and other project stake holders
• Identifies, escalates and communicates any adverse situation that negatively impacts project design, deliverables, cost or timeline
• Collaborates with the equipment owners, Facilities and Validations departments to complete equipment installation, onboarding and associated maintenance activities
• Participates in lessons learned from client projects and fosters an environment of continuous improvement
• Manages external contractors / 3rd parties who are executing project work
• For projects that include infrastructure modifications, the Project Engineer II will be responsible for implementing suitable solutions that incorporate proper civil/construction designs and utility systems designs
• Maintains current knowledge of engineering and pharmaceutical standards from literature and organizations such as FDA/cGMP guidance, ISPE, or other field related consulting/engineering firms
• Works with senior level engineers and department managers in developing client relationships (internal and external) as it relates to the engineering scopes and project deliverables

• MS/BS in an engineering or scientific field with a minimum of 3-5 years of project management experience with a well demonstrated level of performance and capability in the completion of large CAPEX projects for internal and external customers up to $5M
• Demonstrated experience in developing accurate and well defined project scopes, deliverables, cost estimates, and timelines and successfully executing against those items across multiple simultaneous on-going projects
• Understanding of different engineering project phases (conceptual, basic and detailed engineering) is required, including the different scopes, requirements, deliverables and timelines associated with each phase
• Knowledge of relevant engineering principles and theories as well as the capability to use and apply standard engineering procedures and techniques, especially in the field of pharmaceutical process and equipment design and specifications, as well as pharmaceutical facility buildouts and expansion (cleanrooms, utilities)
• Strong knowledge of fields related to pharmaceutical product development process and multiple drug delivery technologies that includes sterile manufacturing, high potent API manufacturing, filling, lyophilization, sterilization (SIP) and cleaning (CIP)
• Demonstrated project engineering experience with facility infrastructure type projects with a strong emphasis on civil and mechanical disciplines for designing and executing facility cleanroom/laboratory buildouts, and pharmaceutical grade utility systems (HVAC, WFI, steam, compressed air, nitrogen, boilers, electrical systems)
• Demonstrated experience with leading and participating in ESH safety analysis and reviews such as HAZIDs and PHAs and implementing proper safety designs into projects
• Strong knowledge of pharmaceutical standards and guidelines for process and equipment requirements based on FDA, ISPE and BPE guidelines for cGMP operations and CSV, CFR 21 compliance for electronic systems
• Strong knowledge and understanding of QMS processes and procedures utilized at the BHM Labs site
• Experience with process and equipment qualification such as FATs, SATs, commissioning, IOQs is required
• Demonstrated experience with understanding and creating engineering drawings such as PFDs, P&IDs, and GAs
• Experience with identifying and establishing strong relationships with suitable equipment and service providers for pharmaceutical manufacturing

Special focus dealing with equipment, processes, and facility designs suitable for use with highly flammable solvent materials and HPAPIs is highly desired

• performance-based remuneration
• occupational health benefits
• hybrid and flexible working environments with #SmartWork
• attractive career paths
• high-quality development programs