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Process Validation Engineer Level 3 - Sterilization

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Date: May 5, 2021

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  27301  

 

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 is an engineering role in the process validation team with an emphasis on sterilization activities. This position is responsible for validating high-volume sterilization equipment and processes. Work will involve assessing product and process risk(s) and understanding equipment and process parameters, writing, executing and reviewing protocols and reports and ensuring all procedures are followed.

 

ESSENTIAL DUTIES

  • Design, execution, analysis and approval of manufacturing IQ, OQ and PQ protocols and reports.
  • Perform independent evaluation, selection, and application in making adaptations and modifications to projects.
  • Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects.
  • Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
  • Implements and understands FDA or regulatory requirements as necessary.
  • Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas.
  • Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.                 
  • Advises team members pro-actively on technical ideas and promotes skill development of team work.
  • 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).

 

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 5 years experience.
  • Two years of GMP manufacturing experience required.

 

Skills

  • Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.
  • 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. 
  • Strong proficiency in validation, commissioning and qualification principles and techniques, and demonstrated ability in successfully applying that knowledge.
  • 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.
  • Practical experience with quality risk management, FMEAs, and risk-based validation approaches.
  • Previous experience with Distributed Control System (DCS), Building Automation Systems (BAS), PLCs, SCADA, and MES is a plus.
  • 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
  • Experience with Wonderware InTouch, System Platform, and Allen-Bradley ControlLogix is a plus.

 

Target Pay Range:  $91,300.00 to $114,100.00  -  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 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.


Nearest Major Market: Denver

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