Compliance Engineer
Thermo Fisher Scientific
- Allentown, PA
- Permanent
- Full-time
- Bachelor’s degree (B.A./B.S.) from a four-year college/university
- Conducts all activities in a safe and efficient manner
- Applies Good Manufacturing Principles.
- Demonstrates and promotes the company vision
- Leads, manages and coordinates departmental quality related activities for Facilities by improving the use of current and existing processes to complete TrackWise deviations, complaints, CAPAs, observations, change controls, and effectiveness checks in a timely manner while enabling clients to optimally analyze product impact.
- Works collaboratively with Quality Assurance and leads other Facilities Department Managers and EHS on solutions in all areas of regulatory compliance.
- Assures all Facility services meet current GMP requirements.
- Leads Facilities Computerized System activities for GMP and Data Integrity Compliance for building maintenance/calibration through oversight of the Maximo CMMS System and Siemens Building Automation (BAS).
- Assists in projects and leading teams that focus on improving existing processes or in development of new processes and or capabilities.
- Gathers and reports Facilities data on both a departmental and business level in order to define gaps and maintain standards of operation including, training, quality systems, planning and scheduling, and operational efficiency metrics.
- Review methods to improve business processes through PPI teams and Lean initiatives based upon critical metrics.
- Other duties may be assigned to meet business needs
- 5 years experience working in a production environment
- Proficiency in Trackwise or similar Quality Management System
- Proficiency in Maximo or similar CMMS planning utility
- Day-to-day knowledge plant operations (Maintenance & Engineering)
- Knowledge of Microsoft Suite (i.e. Excel, Access, Word, PowerPoint)
- Experience in statistical methods and data analysis
- Ability to develop and modify Power BI and other analytical systems macros and custom applications as it pertains to the Microsoft Office environment.
- Experience in process improvement, Lean Manufacturing, and root cause analysis
- Ability to write technical concepts clearly and concisely with good punctuation and grammar.
- Ability to read and interpret GMP and other regulatory requirements
- Ability to work optimally and accurately in a fast-paced environment
- Must possess the ability to define problems, collect data, establish facts, and draw valid conclusions.
- Effectively interact with internal contacts at all levels company-wide (IT, QA, Operations, Client Services, Supply Chain, etc.).
- Must have the ability to effectively present information and respond to questions from senior management, peers, and clients.
- Able to work independently and in a team environment
- Strong written and verbal communication skills
- Excellent prioritization skills
- Task and detail oriented
- Independent problem solver
- Ability to multi-task/handle multiple projects and strong ability to drive tasks/projects to closure by project deadline.
- Walk frequently (50% - 79%)
- Sit (up to 49%)
- Bend frequently (50%-79%)
- Squat (up to 49%)
- Vision requirements for this position: close vision (clear vision at 20 inches or less), distance vision (clear vision at 20 feet or more), color vision, peripheral vision (ability to observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point), depth perception (three dimensional vision) and the ability to adjust focus.
- Personal Protective Equipment Certification (PPE) including but not limited to filtering face masks, PAPR, N- 95 masks, half face masks and safety glasses is required to perform this position
- Work in both hot/cold environments (up to 79%)