Thermo Fisher Scientific

Operations Process Engineer II

Thermo Fisher Scientific • $75K — $95K *
Cincinnati, OH 45238In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor’s Degree in Engineering or Science required
  • Minimum 2 years experience in continuous improvement or as Operations SME
  • Preferred experience in quality, process, and manufacturing investigation
  • Familiarity with cGMP requirements is preferred
  • Lean Six Sigma problem-solving skills preferred
  • Proficiency in Microsoft Office Word, Excel, and PowerPoint
  • Ability to learn and navigate investigation and quality systems

Responsibilities

  • Lead process improvements for the Operations department
  • Participate in quality incident response and root cause analysis
  • Facilitate discussions between cross-functional teams for alignment
  • Aid investigations of production deviations to ensure compliance
  • Support resolution of department critical corrections
  • Revise and maintain manufacturing procedures for GMP compliance
  • Analyze Quality metric data to drive right first time initiatives
  • Participate in inspection readiness activities in Manufacturing Areas

Benefits

  • Medical, Dental, & Vision benefits effective Day 1
  • Paid Time Off & Designated Paid Holidays
  • Retirement Savings Plan
  • Tuition Reimbursement
Full Job Description

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:

The Operations Process Engineer II is a critical member of the Operations Team. The Operations Process Engineer II’s primary responsibilities are: 1) developing robust and compliant procedures for Operations, 2) executing corrective actions for process failures, and 3) driving continuous improvements to address gaps in process.Operations Process Engineers are Subject Matter Experts (SMEs) of Oral Solid Dose manufacturing and are key support personnel for Operations troubleshooting and problem solving.

The Operations Process Engineer team’s current focus is ondriving quality improvements to achieve department right first time (RFT) and quality compliance goals. Operations Process Engineers also assists in leading department quality investigations to resolve the root cause and identify both corrective & preventative actions for top quality losses. 

A Day in the Life:

  • Proactively leads process improvements for Operations 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

   

Keys to Success:

  • Bachelor’s Degree in Engineering or Science related field is required
  • Minimum 2 years experience in continuous improvement, Operations SME, and/or Technical SME
  • Quality, process and manufacturing investigation and technical writing experience is preferred
  • Background in cGMP’s requirements is preferred
  • Lean Six Sigma problem solving skills is preferred
  • Experienced in Microsoft Office Word, Excel and PowerPoint
  • Ability to learn and navigate through investigation, quality and ERP systems
  • Have flexibility to work various shifts times if needed to complete work content.
  • Proficiency with English Language
  • Equivalent combinations of education, training, and meaningful work experience may be considered
  • Models effective and constructive communication and interactions with technical departments both orally and in writing.
  • Maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills.
  • Requires a passion for problem solving, attention to detail, good interpersonal skills, a sound understanding of cGMPs and Manufacturing/ Packaging.
  • Ability to interact with the operations personnel, QA GMP Services, Manufacturing Engineers, Records/Release, Quality Control, QA Regulatory, Engineering.
  • Autonomously prioritizes daily tasks with little to no oversight and shows attention to detail

 

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

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Thermo Fisher Scientific

More Pharmaceuticals & Biotech Jobs

Find similar Operations Process Engineer II jobs:

NationwideCincinnati, OH