Project Engineer II

Evonik•Birmingham, AL

1d•Hybrid

About The Position

This position is responsible for the management and execution of multiple and simultaneous engineering projects for all of the Evonik businesses at the Birmingham Labs site. Evonik offers a world of opportunities to help shape innovative solutions for a more sustainable, healthier, and vibrant world. With 33,000 colleagues, employees have the chance to explore, thrive, and grow through attractive career paths and high-quality development programs. The company provides performance-based remuneration, occupational health benefits, and hybrid and flexible working environments with #SmartWork. Evonik is a thriving global organization that combines cutting-edge science, technology, and engineering with world-class business services to create solutions for real-world problems. Employees are expected to take ownership of their work, collaborate with others, and contribute to creations that make a positive difference. As a world leader in specialty chemicals operating in over 100 countries with more than 32,000 employees, Evonik values diversity of thought and offers opportunities for improvement and respect for contributions.

Requirements

MS/BS in an engineering or scientific field.
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.

Nice To Haves

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

Responsibilities

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.
For capital projects, manage entering, approving, budgeting, forecasting, and reporting in Evonik’s capital project software, EPIC.
Act as the Engineering Lead for assigned projects and assemble a cross-functional team to drive the engineering activities.
Develop project scopes that include complex process designs, project plans, and project deliverables.
Collaborate with internal and external clients and other critical stakeholders to verify the design is innovative, robust, and meets the project requirements.
Identify equipment lists and specifications with suppliers, create engineering drawings (PFDs, P&IDs, general arrangement), and specify facility requirements or modifications to meet the project deliverables.
Build well defined cost estimates and timelines for the project scope that includes all engineering phases (conceptual, basic, and detailed engineering), equipment procurement, installation, and qualification.
Communicate this information to the client (internal and/or external) and other project stake holders as part of an engineering proposal that identifies key tasks and deliverables with the aligned cost and timeline estimates.
Manage project related procurement processes from initial quoting to final invoicing.
Collaborate with Evonik Safety to execute risk and hazard analysis associated with projects and implement any mitigating safety requirements as part of the project scope.
Perform costs analysis and review alternative project designs to implement best business solutions that optimize costs and functionality based on project needs in accordance with Evonik’s EMCI process.
Coordinate and execute all required QMS processes and procedures related to engineering projects, such as QRM (quality risk management – Risk Assessments), Trackwise Change Control, and deviations if observations are made during execution of the project.
Communicate general project status including cost and timeline forecasts to the client (internal and external) and other project stake holders on a timely basis.
Identify, escalate and communicate any adverse situation that negatively impacts project design, deliverables, cost or timeline in a timely and effective manner to the client (internal or external) and other stake holders.
Assess any mitigating actions to alleviate or lessen the impact and provide paths forward.
Collaborate with the equipment owners, Facilities and Validations departments to complete equipment installation, onboarding and associated maintenance activities as well as assist in the qualification testing of the equipment or process.
Participate in lessons learned from client projects and foster an environment of continuous improvement.
Integrate the changes and improvements into the project engineering management process.
Manage external contractors / 3rd parties who are executing project work.
If the project work is installation or construction related, responsible for site management of the contractors, including safety reviews and permitting.
For projects that include infrastructure modifications, implement suitable solutions that incorporate proper civil/construction designs and utility systems designs (such as water systems, boilers, steam, HVAC, refrigeration, electrical, compressed air, etc).
Maintain current knowledge of engineering and pharmaceutical standards from literature and organizations such as FDA/cGMP guidance, ISPE, or other field related consulting/engineering firms and incorporate such standards into assigned projects as appropriate.
Work with senior level engineers and department managers in developing client relationships (internal and external) as it relates to the engineering scopes and project deliverables.