Job Description
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 originality and judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. Performs work which requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of related specialties. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.
ESSENTIAL DUTIES
- 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), and Performance Qualification (PQ) protocols/report in accordance with established procedures.
- Reviews, approves, and support validation activities conducted by approved suppliers. Ensures validation records comply with regulatory and corporate requirements.
- Perform Validation Periodic Review for various systems, including automated manufacturing equipment, computerized systems, and test equipment.
- 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).
- 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
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 4 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 trouble-shooting.
- 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.
-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.
LOCATION
Lakewood, Colorado - Onsite.
Desired Skills and Experience * 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 trouble-shooting.
* 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.
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