Engineer 3 - Validation & Quality

Requisition ID: 33408

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. For Terumo, for Everyone, Everywhere.

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. Advancing healthcare with heart.

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. Join us and help shape wherever we go next. You create your future and ours.

This position is responsible for supporting the validation and quality engineering of various systems in a medical device manufacturing environment and assure the equipment/system and validation records are compliant with company standards and industry practices. This role ensures compliance with regulatory and quality system requirements while driving continuous improvement in validation and quality practices. The engineer will collaborate cross-functionally to develop, execute, and maintain validation protocols, support nonconformance investigations, and contribute to the Corrective and Preventive Action (CAPA) process.

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), and Performance Qualification (PQ) protocols/report in accordance with established procedures.
• Carry out all aspects of Test Method Validation including: creating test/measurement methods, executing statistical analysis of test method results, authoring and executing test method validation protocols and reports in accordance with established procedures.
• Reviews, approves, and support validation activities conducted by approved suppliers. Ensures validation records comply with regulatory and corporate requirements.
• Perform Validation Periodic Review for various systems, including automated manufacturing equipment, computerized systems, and test equipment.
• Perform independent evaluation, selection, and application in making adaptations and modifications to projects.
• Executes with total project leadership responsibilities on major high complexity projects with total management responsibility.
• Support the Corrective and Preventive Action (CAPA) and Nonconformance (NC) processes to ensure thorough investigation and timely resolution of quality issues. Responsibilities include conducting root cause analysis, leading investigations, performing trend analysis, ensuring timely record completion, and driving effective corrective and preventive actions.
• Collaborate cross-functionally to implement sustainable solutions and maintain compliance with regulatory and quality system requirements. Ensures that process and equipment designs are compliant with all Company policies and procedures as well as all Local, State, and Federal directives, laws, and regulations.
• Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives, and recommending solutions.
• Follows department processes and regularly makes recommendations on these processes.
• Follows technical specification requirements, developing reports, charts, and graphs to support project recommendations and responds to questions from technical staff members and management.
• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.

• Analyzes data with statistical analysis and presents it in appropriate forums.
• Actively participates in Quality System and Good Laboratory Practice (GLP) requirements, particularly with respect to documentation.
• Work assignments may require additional development and a maturing or broadening of in-depth engineering skill(s).
• Support audits (internal and external) by providing documentation, data analysis, and compliance evidence.
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• Contriubutes to the establilshment of business objectives, goals, budgets and costs.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field) or a relevant scientific discipline.

Experience

• Minimum 4 years experience of experience in validation and quality engineering within the medical device industry.
• Experience with equipment qualification (IQ/OQ/PQ), process validation, and test method validation.
• Strong knowledge of FDA regulations, ISO 13485, and Good Manufacturing Practices (GMP).
• Hands-on experience with risk management tools such as FMEA.
• Previous experience supporting CAPA and NC processes, including root cause analysis and corrective actions.
• Experience with ERP and document control systems (e.g., SAP, Windchill) preferred.

Skills

• Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.
• Requires interactive skills in cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior, provides support for subordinates, junior engineers, technicians, and management.
• Ability to work independently and manage multiple projects simultaneously.
• Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues and train and provide work direction to operators and production service technicians.
• Understanding of and adherence to GMP practices and FDA regulations.
• Knowledgeand ability to implement FDA or regulatory requirements as necessary.
• Strong communication and collaboration skills across cross-functional teams.
• Proficiency in statistical analysis tools and validation software.

-Or

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

LOCATION

Lakewood, Colorado - Hybrid Onsite - Open to candidates willing to relocate to the area.

TRAVEL

Requires travel based on business needs.

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.

Target Pay Range:$107,000.00to$133,800.00 -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.