Engineer 3 - Validation & Quality

Requisition ID:  31796  

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. 

This position is responsible for validation and quality engineering support of an ethylene oxide sterilization facility.  In this role, the Validation and Quality Engineer will ensure the equipment/system and validation records are compliant with company standards and industry practices. This position is responsible for validating high-volume sterilization equipment and processes. Work will involve supporting the implementation of new equipment and processes, assessing product and process risk, understanding equipment and process parameters, writing, executing and reviewing protocols and reports and ensuring all procedures are followed.

ESSENTIAL DUTIES

• Carry out all aspects of a validation project, which includes: authoring and executing Validation Master Plan (VMP), Validation Plan (VP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV) protocols/reports in accordance with established procedures.
• Reviews, approves, and support validation and quality activities and ensures records comply with regulatory and corporate requirements.
• Become a subject matter expert on sterilization validations and quality requirements for process, equipment, and associated software.
• Support the nonconformance, CAPA, change control, and audit processes.
• Implements and understands FDA or regulatory requirements as necessary.
• Working knowledge of cross-functional and related technical areas.
• Works with quality management, operations and other functional groups on regulatory and quality system compliance. 
• Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects.
• Highlights risks and understands how to approach and complete tasks efficiently.                  
• Advises team members pro-actively on technical concepts, works collaboratively with cross functional teams.
• Effectively presents complex technical information/analysis, and responds to questions from technical staff members and management.   
• Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).
• Work direction responsibility may include technicians and junior engineers.
• May work with operations and other functional groups on regulatory compliance issues.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.

Experience

• Minimum 4 years experience.
• Two years of GMP manufacturing experience required.

Skills

• Requires demonstrated skills in validation and quality engineering.
• Strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.
• Strong technical problem-solving skills.
• Mechanical and electronic ability aptitude to assist with equipment troubleshooting.
• Understanding of and adherence to GMP practices and FDA regulations.
• Knowledge and ability to implement FDA or regulatory requirements as necessary.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge and use of relevant PC software applications and skills to use them effectively. 
• Uses a Risk based approaches to solving quality issues that arise and validation applications
• Knowledge of Test Method Validation, Lean Six Sigma, and Continuous Improvement concepts and implementations.
• Knowledge and use of Electronic Quality Systems for quality management activities
• Strong proficiency in validation, commissioning and qualification principles and techniques, and demonstrated ability in successfully applying that knowledge.
• Ability to work independently, organize and manage individual as well as lead larger scale projects.
• Strong technical writing, verbal communication, interpersonal and problem-solving skills.
• Practical experience in developing and executing equipment and Computerized System Validation (CSV) deliverables for automated equipment and control systems but not limited to Validation Plans, Risk Assessments, IQ/OQ/PQ protocols and reports, Trace Matrices, Process Validation Summary reports, compliant with global validation policies and procedures
• Experience with Wonderware InTouch, System Platform, and Allen-Bradley ControlLogix is a plus.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Additional Requirements

Requires travel based on business needs. 

Requires project work during sterilization facilities non-operational hours, if requested.

Target Pay Range:  $99,200.00 to $124,000.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  7.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
• We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  • Respect – Appreciative of others
  • Integrity – Guided by our mission
  • Care – Empathetic to patients
  • Quality – Committed to excellence
  • Creativity – Striving for innovation
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.