Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Discover Impactful Work:

A Day in the Life: 

• Proactively leads quality improvements for the department.
• Participates in quality incident response, including initial response and containment, and utilizes Practical Problem Solving tools and principles to aid in root cause analysis and identification of corrective actions.
• Facilitate discussions between cross-functional teams (Quality, Tech Services, Engineering, etc.) in order to drive alignment on quality incident root cause and correction actions
• Aid in investigations of production related deviations of batches, preps, lots, equipment, and facilities to ensure all cGMPs, SOPs, product registrations, and customer requirements are met. Performs final functional area approval for operations owned deviation investigation reports to ensure report accuracy and alignment on root cause and correction action(s).
• Support resolution of department critical corrections / facilitate alignment on process comments and batch records notes per cGDP.
• When appropriate, revise and maintain Manufacturing procedures and forms to ensure GMP compliance.
• Support Manufacturing systems to proactively identify and address quality risks, including Daily Gemba process and Quality Suggestion Program.
• Track and analyze Quality metric data for Manufacturing department to drive RFT initiatives
• Participates in inspection readiness activities in Manufacturing Areas
• Author digital forms for executing setup/run/clean batch activity in Digital Logbook system
• Displays competency in supporting multiple Operations Departments as an SME of manufacturing processes
• Represent Operations when appropriate in PPI Kaizens and workshops
• Represents Operations, when necessary, in client-facing situations, including client tours and calls, or regulatory audits and inspections
• Represents Operations Process Engineering Team in cross-functional project team settings including equipment validation, cleaning validation, and engineering phase review meetings, etc.

 

Keys to Success:

• Bachelor’s Degree in Engineering or Related Field is required

• Previous experience as Operations Process Engineer II, 2+ years is preferred
• ​Minimum 3 years experience in a Quality or Operations role is required
• Quality, process and manufacturing investigation and technical writing experience is required
• Background in cGMP’s requirements is required
• Demonstrated Lean Six Sigma problem solving skills is required
• Previous experience demonstrating GMP understanding and competency in client communications, including tours, visits and calls
• Previous experience in Regulatory audits 
• Ability to inspire change and lead multiple projects
• Previous experience navigating through investigation, quality and ERP systems (i.e. TrackWise, SAP, etc.)
• Demonstrate high competency in using digital tools, preferred prior experience authoring in Digital Logbook system
• Demonstrated ability to lead multiple process improvement projects and sustain change management
• Experienced in Microsoft Office Word, Excel and PowerPoint, and project management tools
• Have flexibility to work various shifts times if needed to complete work / training on all shifts
• Proficiency with English Language

Excellent Benefits

• Benefits & Total Rewards | Thermo Fisher Scientific

• Medical, Dental, & Vision benefits-effective Day 1

• Paid Time Off & Designated Paid Holidays

• Retirement Savings Plan

• Tuition Reimbursement

OTHER

• Relocation assistance is NOT provided

• Must be legally authorized to work in the United States now or in the future, without sponsorship.

• Must be able to pass a comprehensive background check, which includes a drug screening