Compliance Engineer

at  Thermo Fisher Scientific

JOB DESCRIPTION

When you are part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labeling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards. http://www.fisherclinicalservices.com/

EDUCATION

• Bachelor’s degree (B.A./B.S.) from a four-year college/university

KNOWLEDGE, SKILLS ABILITIES:

• 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.

PHYSICAL REQUIREMENTS

• 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%)
  At Thermo Fisher Scientific, each one of our 67,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer

WHAT WILL YOU DO?

The Compliance Engineer supports day-to-day operations in the areas GMP Compliance, Audit Support, eDMS, SOP Development/Review and Metrics. This position provides analytics, investigations of deviations, activities (PRs/QRs) Trackwise, coordinates Corrective/Preventative Actions (CAPAs), PERs, resolutions and improvements.

RESPONSIBILITIES:

• 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