Job title: Validation Engineer 3
Company: Terumo BCT
Job description: Requisition ID: 26785
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.
The Product Quality Validation Engineer will be responsible for generating validations for Terumo BCT and Test Method Validation activities, which includes reviewing process parameters and requirements, assessing product and process risk, and understanding equipment to be utilized. This position will also be responsible for supporting process and test method validation activities as needed by the team; this includes but is not limited to maintaining the validation master plan, reviewing protocol and report documents, and ensuring the procedures used to validate processes are adhered to.
Work requires the use of judgment with respect to the application and adaptation of standard techniques, procedures, and criteria
- Independently performs validation activities as dictated by assigned project responsibilities.
- Project lead assuming responsibilities for major projects and various smaller projects.
- Implements and understands FDA or regulatory requirements as necessary.
- Demonstrated ability to work independently and lead cross-functional teams.
- Ability to plan schedules and provide creative solutions to address potential schedule delays.
- Interacts with peers across projects to secure resources and commitments.
- Handles frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
- Follows technical specification requirements and provides feedback on various technical processes and procedures.
- Presents effectively 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).
OTHER DUTIES AND RESPONSIBILITIES
- Work direction responsibility may include technicians and junior engineers.
- May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
MINIMUM QUALIFICATION REQUIREMENTS
- Bachelor of Science Degree in Engineering, preferred.
- Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
- Minimum 5 years’ experience.
- Two years of GMP manufacturing experience required.
- Requires demonstrated skills in technical innovation, technical leadership, mechanical, chemical engineering, industrial, or electrical engineering.
- Strong interactive skills in communication, cross-functional team interactions, technical leadership, project management, and support for subordinates, junior engineers, technicians, and management.
- Strong technical problem-solving skills. Strong graphical and statistical analysis skills
- Mechanical and electronic ability aptitude to assist with equipment troubleshooting.
- Understanding of and adherence to GMP practices and FDA regulations.
- Understanding of measurement system analysis and test method validation approaches.
- Knowledge and ability to implement FDA or regulatory requirements as necessary.
- Demonstrated ability to communicate effectively both verbally and in writing.
- Demonstrated ability to effectively use of relevant PC software applications. Familiarity with Minitab preferred.
An equivalent competency level acquired through a variation of these qualifications may be considered.
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 Physical Requirements
Requires travel based on business needs.
- 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.
Location: Lakewood, CO
Job date: Wed, 18 Nov 2020 05:52:39 GMT