Engineer 2 - Validation
Company: Terumo BCT, Inc.
Posted on: February 6, 2024
Requisition ID: 31502
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
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
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.Work requires independent evaluation, selection
and application of standard engineering techniques, procedures, and
criteria, using judgment and ingenuity in making minor adaptations
and modifications. Assignments include equipment and process
validation, tests method validation, process characterization,
research investigations, report preparation and other activities of
limited scope. Duties are assigned to provide experience and
familiarization with engineering methods, independent thinking, and
company practices and policies.
- 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),
protocols/report in accordance with established
- Perform Validation Periodic Review for various systems,
including automated manufacuturing equipment, computerized systems,
and test equipment.
- Analyze information, draw the right conclusions based upon
technical knowledge of the systems, and work effectively with
different groups across site to determine status, gaps and
- Provide technical input with respect to Standard Operating
Procedures development. Revise or develop SOP's as required to
assure that all needs are addressed, and compliance and industry
standards are incorporated.
- Perform equipment risk assessments to assess impact of system
functionality and control on product quality and troubleshoot
equipment/system when errors occur in order to provide recommended
- Represent Validation and participate on cross-functional teams
to assist with non conformance investigation, CAPA and change
- Maintain up-to-date knowledge of validation requirements,
practices, and procedures and coach other members of the team
participating in validation activities.
- Ensure that projects are implemented in accordance within the
agreed scope and timelines.
- Conducts studies and makes recommendations for the purchase and
implementation of new technologies, practices, tools, and equipment
to maximize site effectiveness.
- Provides work direction to engineering support staff.
- Takes initiative and demonstrates inquisitive approaches to
solve moderately complex problems, indentifying problems,
generating alternatives and recommending solutions.
- Follows department processes and regularly makes
recommendations on these processes.
- Works cooperatively and effectively in a team environment or
across teams to achieve common goals and results.
- Analyzes data and presents it in appropriate forums.
- Actively participates in Quality System and Good Laboratory
Practice requirements, particularly with respect to
- Work assignments may require additional development and a
maturing or broadening of in-depth engineering skill(s).
- May work with manufacturing and other functional groups on
manufacturing and regulatory compliance issues.
MINIMUM QUALIFICATION REQUIREMENTS
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.
Minimum 2 years experience.
Two years of GMP manufacturing experience required.
- Requires demonstrated skills in technical innovation, technical
- 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.
- Mechanical and electronic ability and aptitude to assist with
- 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
- Knowledgeand 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.
An equivalent competency level acquired through a variation of
these qualifications may be considered.
Onsite at our Littleton, CO facility.
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
Additional Physical Requirements
Requires travel based on business needs.
Target Pay Range:$78,500.00to$98,100.00 -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
- 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
- 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
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.
Keywords: Terumo BCT, Inc., Littleton , Engineer 2 - Validation, Engineering , Littleton, Colorado
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