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Form of workJob Description
We're ALTEN Technology USA, an engineering company that provides solutions for engineering, technology, and product development projects. For decades, we've been helping our clients develop products that are changing the world, whether that's by shaping the future of space exploration, saving lives with medical devices that set a new standard of care, or creating the fully autonomous electric taxi of tomorrow. Our team of more than 600 people works across industries including aerospace, medical devices and life sciences, unmanned systems and robotics, automotive OEM and tier 1 suppliers, commercial vehicle, electric vehicles, rail, and more. Our offices across the US have different industry focuses and engage with our clients in different ways, ranging from working on-site at client facilities to performing product development at our delivery centers.
ALTEN Group, our parent company, has been a leader in engineering and information technology for more than 30 years. ALTEN Group operates in 30 countries across Europe, North America, Asia, Africa and the Middle East and employs more than 36,000 people, 88% of whom are engineers. The company covers the whole development cycle and offers a choice of service levels, from technology consulting to complete project outsourcing.
When you join ALTEN Technology USA, you join a group of people passionate about collaborating to solve some of the world's most technical engineering challenges. Our success is tied to taking care of our employees by building relationships and providing opportunities for mentorship and career growth. We offer comprehensive benefits for all full-time employees, including medical, dental, and vision insurance; a 401(k) plan with employer matching; paid time off (PTO); paid parental leave; and mentorship to help you take your career to the next level. You don't have to take our word for it that we are a great place to work—we were named on the 2023 Top Workplaces list thanks to feedback from our proud employees.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- 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 procedures.
- Perform Validation Periodic Review for various systems, including automated manufacturing 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 corrective actions.
- 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 actions.
- Represent Validation and participate on cross-functional teams to assist with non conformance investigation, CAPA and change controls write-up.
- 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, identifying 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 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.
Education/Experience
- 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 5 years experience.
- 5 years of GMP manufacturing experience required.
Qualifications: The requirements listed below are representative of the knowledge, skills, and/or abilities required.
- Requires demonstrated skills in technical innovation, technical leadership.
- 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.
Salary Range: $115,000-135,000
The actual salary offered is dependent on various factors including, but not limited to, location, the candidate's combination of job-related knowledge, qualifications, skills, education, training, and experience.
Location: Littleton, CO
ALTEN Technology is an Equal Opportunity Employer. Our Policy is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual's age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity/expression or veteran status.
