job summary: Quality Engineer $100K, 12% yearly Bonus Oakbrook, IL 1 st Shift - M-F Hybrid - 2 days a week onsite 5-7 years of Pharmaceutical/Food Industry experience Background in Validation and QA/Compliance Extensive Validation experience, skilled in Process, Equipment, Utilities, Facilities, Cleaning and Equipment Validation Extensive Qualification experience (IQ, OQ, PQ) Experience hosting FDA Audits Experience with Root Cause Investigations and CAPA Excellent communication skills JOB SUMMARY This position is responsible for planning, executing, and summarizing validation strategies and the calibration activities of instrumentation, equipment, and processes used to manufacture products that demonstrate consistent and reproducible results; managing the metrology program; and providing/overseeing engineering and technical support for Quality in the Manufacturing areas. Through professional staff, he/she establishes and maintains metrology standards, procedures, and controls. The incumbent works directly with manufacturing to schedule and control inspection activities and to enforce requirements as specified by equipment specifications, and regulatory agency expectations. The incumbent is also responsible for creating and reviewing qualification documents related to equipment, facility utilities, analytical instruments, and computerized systems. He/she trouble-shoots validation and calibration issues, proposes solutions and leads the effective implementation of identified CAPA. This role has full authority to operate this position in accordance with Company policy and as directed by the Assistant Director, Quality. location: Oak Brook, Illinois job type: Permanent salary: $90,000 - 100,000 per year work hours: 8 to 4 education: Bachelors responsibilities: ESSENTIAL JOB FUNCTIONS 1. Manages the development and execution of process and cleaning validation activities including study protocols and report generation. 2. Manages the development and execution of IQ/OQ/PQ activities related to the introduction of new equipment in conjunction with Manufacturing Engineering. 3. Provides resolution of non-conformances including root cause determination, corrective/preventive action (CAPA) plan development and verification of effectiveness. 4. Manages the Technical Change Control system and works with Manufacturing personnel to develop process changes to improve production process performance. 5. Manages the Company's metrology program (including all required internal and external calibration functions). 6. Supervises Validation staff including performance management and professional development. 7. Provides Quality support to the launching of new or improved product/processes. 8. Assists in improving process performance, including development of process diagrams, analysis of performance using Design of Experiments, process capability/performance measurements (Cpk/Ppk), and development of quality control plans. 9. Creates and revises Company's calibration procedures and manages calibration standards and equipment/instrument calibration history files. 10. Trouble-shoots validation and calibration issues, proposes solutions, and leads the effective implementation of identified CAPA. 11. Develops, maintains, and adheres to project timelines and implementation plans. 12. Interacts with all internal departments in order to drive continuous quality improvements in the organization. ADDITIONAL RESPONSIBILITIES 1. Develops and implements creative validation strategies, system implementations, and statistic/trending analyses to achieve department and organization objectives. 2. Participates in facility audits and on issue-specific committees. 3. Provides technical support regarding validation activities during inspections by external parties. 4. Performs and assumes other duties and responsibilities, as may be required by the Director, Quality and/or Vice-President,Operations. qualifications: REQUIRED EDUCATION, EXPERIENCE AND SKILLS 1. A 4-year technical college degree in specialized fields such as science or engineering or, its equivalent in training and experience is required. 2. The knowledge and skills required for this position are typically acquired in 3 to 5 years of experience in a pharmaceutical Quality, Validation, or Engineering functional area. 3. American Society of Quality (ASQ) Certification as a Quality Engineer (CQE) is preferred. 4. Attention to detail and ability to work well under pressure. 5. Knowledge of statistical sampling and analysis, including DOE design. 6. Must have a thorough understanding of current Good Manufacturing Practices (cGMP). 7. Able to prioritize projects and manage Validation resources to meet organizational goals and objectives. 8. Trained in Greenbelt, Blackbelt, or similar Six Sigma methodology, preferred. 9. Strong validation and metrology background with experience and working knowledge of the following: NIST, ANSI, and ASTM. 10. Technical skills in various types of Validations including but not limited to: - Facility systems - Product - Processes - Equipment - Computer Systems - Commodity and Packaging 11. Able to lead risk analysis including FMEA's. 12. Must have excellent interpersonal skills to interact with various levels of internal and external customers. 13. Must have excellent verbal and written communication skills in business English. 14. Computer literate in a Windows environment (Proficient computer skills in the following programs: MS Office, MS Project, Visio, and Auto-Cad are preferred). 15. Excellent organizational ability and project management skills. 16. Must have the ability to work independently and meet deadlines on a multitude of concurrent tasks. 17. Must possess strong analytical ability. 18. Must have strong math aptitude. (Usage of addition, subtraction, multiplication, division, fractions, the ability to calculate percentages, percentage deviations, tolerances, ratios, bias, and a basic understanding of statistics.) 19. Willingness to accept other duties, assigned. 20. Must be discreet with confidential information of which he/she has access. 21. Must possess the ability to develop and maintain an effective working relationship with internal and external customers, function as a team player, accept constructive criticism from management, and comply with Company policies. JOB DESCRIPTION ENVIRONMENT 1. This position requires the individual to stand or walk up to 33% of the time. This position requires the individual to sit, talk or hear, and use hands to finger, handle or feel 66% to 100% of the time. This position requires the individual to reach with hands and arms 33% to 66% of the time. 2. This position will require the individual to lift up to 10 pounds 33% to 66% of the time. 3. The vision requirements for this position includes close vision of 20 inches or less; distance vision of 20 feet or more, color vision (ability to distinguish between colors), peripheral vision (ability to see up, down, left, right while eyes are fixed on a given point), depth perception (3-dimensional vision), and ability to adjust focus (ability to adjust the eye to bring an object into sharp focus). 4. This position has no exposer to measurable environmental hazards or conditions. 5. The noise level for this position will be moderate noise (ex: Business office with typewriters and/or computer printers, light traffic). skills: GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.