Engineering Manager - Process Validation

at Terumo BCT

Denver, CO

Posted on Jul. 20, 2016

Leads specified engineering team supervising detailed engineering work on a specific portion of a broader task assigned to experienced engineers. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.

* Managing a team of process validation engineers and contractors to ensure the process validation work is performed according to TerumoBCT requirements.
* Maintaining up-to-date knowledge of validation standards and regulatory compliance requirements and independently contributes to the development of new validation standards
* Contributing to long-term strategic development of validation projects with the process development team.
* Updating the Validation Master Plan and ensuring it is completed according to schedule.
* Forecasting project and staffing requirements
* Providing oversight and technical guidance for protocol and report generation and process characterization studies.
* Resolving technical issues encountered during process validation execution.
* Interacting with regulatory agencies during inspections to speak to validation program and questions related to process validation life cycle.
* Maintaining the Process Validation procedures at the Lakewood TerumoBCT facility; this includes the Policy, Procedures for IQ, OQ and PQ, Revalidation and Process Requirements.
* Ensuring training of employees and contractors throughout Lakewood TerumoBCT to assure up-to-date knowledge of practices and procedures.
* Contribute validation input and represent the validation function on cross-functional teams.


* 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.
* Responsible for the project and or work group expenditures vs. plan.
* Implements and understands FDA or regulatory requirements as necessary.
* Ensures compliance with Quality System regulations and safe working practices.
* Plans, guides, and reviews projects and or work groups under one's control to produce the desired outcome.
* Utilizes technical skills to evaluate proposed solutions, adaptations, and modifications to projects.


* 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 10 years experience.

* Experience managing validation, quality, or engineering operations in a manufacturing environment in a cGXP regulated facility.
* Strong knowledge of validation (facilities, equipment, process and software) with documented experience in medical device/biotechology/pharmaceutical industry.


* Demonstrated skills in technical innovation, technical leadership, mechanical or chemical engineering, fluids engineering, and cellular biology.
* Strong interactive skills in 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.
* Represents the organization as the prime technical contact on projects. Interacts with senior level external associates on significant technical matters often requiring coordination between organizations.
* Follows and develops technical specification requirements and provides significant input on technical procedures for various processes that impact multiple disciplines.
* Driver for acquiring resources and building consensus across products.
* Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
* Regularly and effectively presents complex technical information/analysis, and responds to questions from technical staff members and management.
* 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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