Process Validation-Engineer II

at Terumo BCT

Denver, CO

Posted on Sep. 8, 2016

This position will be part of the process validation team. This position will be responsible for writing validation plans, protocols, reports and writing validation procedures for new process development projects. This position may be responsible for managing and on-boarding process validation contractors, completing requirements documentation, sustaining and improving the process validation system, maintaining the validation master plan and reviewing IOPQ documents.
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 design and development, tests of materials, preparation of specifications, process study, 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.

* Provides specification, procurement, installation, start-up, and commissioning activities for manufacturing equipment, facilities areas, and process utilities systems.
* Manages projects including development of project scope and estimates, initiation of requests for capital when required, specification of equipment and installation requirements, management of costs to budget, and support of IQ/OQ and final documentation in accordance with acceptable engineering practices.
* Conducts studies and makes recommendations for the purchase and implementation of new technologies, practices, tools, and equipment to maximize site effectiveness.
* Prepares and reviews engineering/technical documents such as reports, SOP's, protocols, schedules and budgets, and vendor provided documents and drawings.
* 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.
* 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.
* 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 and presents it in appropriate forums.
* Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentation.


* 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.


* 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.


* Experience with process validation, validation of automation would be beneficial but not required.
* 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.
* Mechanical and electronic ability and aptitude to assist with equipment trouble-shooting.
* 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.
* 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.

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.

* Requires travel based on business needs.

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, 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.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace.

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