Maintenance Quality Engineer

What we offer

Explore a world of opportunities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable. At Evonik, you have the chance to explore, thrive, and grow alongside 33,000 colleagues. Among attractive career paths and high-quality development programs, we not only offer performance-based remuneration and occupational health benefits but also hybrid and flexible working environments with #SmartWork. Bring your fresh perspective, develop your strengths, break out your mold, and find a career that fits your dreams with us.

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This position will be the primary owner of Facilities department Quality programs, including management of change, deviation investigations, and implementation of corrective / preventive actions stemming from audits and quality-related incidents. As program owner, this position will be responsible for on-time closure of all Quality records, via both direct execution by this position and by assisting / coordinating other positions in the department with their assigned records. Additionally, this position serves as the technical lead on maintenance topics related to development-scale equipment such as reactors, homogenizers, etc. The Maintenance Quality Engineer will identify critical spare parts, develop maintenance work instructions for technicians to execute, and directly assist technicians with execution and troubleshooting. Finally, this position will help drive the desired “utilities as processes” mentality by tracking and reporting daily utility (steam, water, etc.) data, analyzing for outliers, and proposing improvement actions.

RESPONSIBILITIES

​Quality Program

• Own TrackWise backlog for Facilities Department to ensure backlog remains in compliance at all times. Indirectly manage other Facilities employees when necessary to achieve this.
• Write high-quality management of change documents; modify as necessary based on feedback from Quality Assurance and affected departments.
• Perform and document investigations of Facilities-related deviations, including possible preventive and corrective actions.

Development Laboratory Equipment

• Identify critical spare parts by analyzing maintenance history and leading FMEA (Failure Mode & Effect Analysis) exercises. Execute improvement by adding lacking critical spare parts (including vendor selection) and removing unnecessary spare parts from site inventory.
• Identify and implement preventive maintenance best practices.
• Write work instructions for preventive maintenance tasks and provide hands-on training for the technicians who will execute them.
• Assist technicians with troubleshooting equipment problems.

Utility Status Log

• Develop and own the Facilities Utility Equipment Status Log.
• Monitor established equipment routines. Analyze the data using statistical methods and make recommendations for system/equipment improvements.

General

• Support customer and regulatory audits (including FDA) by providing requested data and participating in auditor interviews as a subject matter expert for certain topics.
• Incorporate Good Maintenance Best Practices to ensure safe reliable performance.
• Identification and implementation of applicable codes, standards and Generally Accepted Good Engineering Practices. (RAGAGEP)
• Plan, coordinate, and execute assigned small projects by effectively using project management methodologies, i.e. PMBOK, MS Project, etc.
• Read and review engineering drawings and technical manuals and update as required.
• Prepare reports for site management on evaluation and recommendations for improving maintenance practices, code compliance and documentation.
• Follow SOP’s, cGMP, and GLP regulations and procedures; generate and maintain thorough and accurate documentation by using Good Documentation Practices (GDP). Adherence to all written instructions. Ensure to maintain the work area in a state of cleanliness and sanitation through good housekeeping practices and applying good personal health. Interact and communicate effectively with clients on technical aspects of the project.
• Follow Environmental, Safety, and Health practices and procedures in accordance with current Local, State, and Federal regulations; use personal protection equipment (PPE) appropriate to the type of hazard and exposure potential. Actively participate in identifying and resolving safety issues.
• Perform other duties as assigned.

REQUIREMENTS

• Bachelor of Science Degree in an Engineering discipline, preferably Mechanical or Chemical.
• 1-3 years of demonstrated Engineering experience in an industrial setting preferred.
• Excellent technical writing skills required. Technical documents written by this position are certain to be reviewed frequently in audits, including high-stakes regulatory audits.
• Prior experience with pumps, compressors, boilers, water purification systems, reactors, homogenizers, extruders, and solids filtration systems is all helpful and relevant to the position.
• Prior experience in the pharmaceutical industry helpful but not required.
• Knowledge of the engineering principles pertaining to facilities design and capable in the operation of standard laboratory, analytical, and/or processing and manufacturing equipment.
• Recognize unanticipated or adverse outcomes or deviations; able to use technical expertise, experience, and creativity to evaluate and identify causes of unanticipated or adverse outcomes or deviations and to propose corrective action or resolutions for problems of increasing complexity; able to independently take corrective action to resolve technical problems of suitable complexity.
• Knowledge of the use of personal protective equipment and safety protocols and practices related to working with or exposure to hazardous chemicals that could potentially affect the health of the employee.
• Ability to:
  • Perform work utilizing a computer.
  • Sit for extended periods of time without being able to leave the work area.
  • Stand for extended periods of time without being able to leave the work area.
  • Grasp objects utilizing the fingers (fine motor manipulation).
  • Reach for objects above the head or below the waist.
  • Stoop or crouch by bending at the waist or by bending the legs.
  • Using eye site be able to determine colors.
• Experienced in the use of word processing, spreadsheet, and presentation software programs, including Microsoft Office Suite tools and SAP R11 maintenance module.
• A thorough understanding and application of relevant scientific theories, principles, and methods; familiarity or general working knowledge of other related technical fields and applications.
• Effective verbal communication skills; ability to clearly and effectively communicate observations, results, and outcomes to more senior technical staff.
• Ability to interact and communicate effectively with senior staff, at internal company meetings, and with clients on technical aspects of facility & equipment projects.
• Actively contribute to the improvement of policy, practices, and procedures.
• Good organizational skills.
• Perform other duties as assigned.

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.

Your Talent Acquisition Manager:

Kelvin Seals [C]

Company is

Evonik Corporation