Project Engineer II

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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.

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, manages entering, approving, budgeting, forecasting, and reporting in Evonik’s capital project software, EPIC. 

• Acts as the Engineering Lead for assigned projects and assembles a cross-functional team to drive the engineering activities.  The cross-functional team may include: internal Evonik engineering services, external engineering services and suppliers, Tech Ops, R&D, Manufacturing, Maintenance, Procurement, Quality, Supply Chain, and Validation depending on the scope of the project.

• Develops project scopes that include complex process designs, project plans, and project deliverables.  Collaborates with internal and external clients and other critical stakeholders to verify the design is innovative, robust, and meets the project requirements.

• 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 that includes all engineering phases (conceptual, basic, and detailed engineering), equipment procurement, installation, and qualification.  Communicates 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.

• Manages project related procurement processes from initial quoting to final invoicing.  Requires collaboration with procurement to define specifications or scopes of work, purchasing justifications, suitability of suppliers to meet equipment and service requirements, entry of PR/POs in SAP and subsequent follow up with suppliers.  Following delivery, communicates with suppliers and Evonik AP to verify accurate and timely invoicing.

• Collaborates with Evonik Safety to execute risk and hazard analysis associated with projects and implement any mitigating safety requirements as part of the project scope.

• Performs 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.

• Coordinates and executes 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.

• Communicates general project status including cost and timeline forecasts to the client (internal and external) and other project stake holders on a timely basis.

• Identifies, escalates and communicates 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. Assesses any mitigating actions to alleviate or lessen the impact and provides paths forward.

• Collaborates 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.

• Participates in lessons learned from client projects and fosters an environment of continuous improvement.  Integrates the changes and improvements into the project engineering management process.

• Manages 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, the Project Engineer II will be responsible for implementing suitable solutions that incorporate proper civil/construction designs and utility systems designs (such as water systems, boilers, steam, HVAC, refrigeration, electrical, compressed air, etc).  Such solutions can be designed from consulting with external engineering firms.

• 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 and incorporates such standards into assigned projects as appropriate. 

• 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.

REQUIREMENTS

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

• 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.

The Evonik Group adopts an Equal Employment Opportunity (EEO) approach.  Candidates are assessed based on their educational qualifications, experience, job competencies and potential and shall not be discriminated against on the basis of race, ethnicity, age, gender, religion, nationality, disability or sexual orientation or other classifications protected by local, state, or provincial regulations.

Your Application
 

To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at https://careers.evonik.com. 

Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations.

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