Rotational Engineer- Validation, Quality
About The Position
Join our Rotational Engineering Program and gain hands-on experience in Validation within the Cadence Quality Organization of a medical device manufacturing environment. This approximately two-year program is designed to provide broad exposure to validation, quality, engineering, manufacturing, and regulatory practices across our organization. You will begin your rotation at our Cadence, Virginia site in Staunton, Virginia, for approximately 12 months before rotating to another East Coast location for the remaining 12 months in our program. As a Rotational Engineer focusing on Validation, you will support validation activities across our eight Cadence facilities, working collaboratively with Engineering, Quality, Manufacturing, and other cross-functional teams. This is a corporate function, so flexibility and the ability to travel to other sites to support validation projects and activities is essential.
Requirements
- Bachelor's degree in Manufacturing, Engineering, or a related field.
- Eligible rotational candidates must have graduated from an accredited four year program within the past 12 months at the start of the program (May 2027).
- Interest in pursuing a career in medical device manufacturing, quality engineering, validation, or regulatory compliance.
- Strong analytical, problem-solving, and organizational skills.
- Ability to interpret technical documentation, procedures, and regulatory requirements.
- Strong written and verbal communication skills.
- Ability to work effectively in cross-functional and geographically distributed teams.
- Attention to detail and a commitment to data integrity and quality.
- Ability to manage multiple priorities and work effectively in a regulated manufacturing environment.
- Willingness and ability to travel to other Cadence facilities to support validation projects.
Responsibilities
- Develop validation protocols and plans in accordance with regulatory requirements and industry standards.
- Define validation scope, objectives, acceptance criteria, and testing methodologies.
- Contribute to the development and maintenance of the organization's Master Validation Plan (MVP).
- Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for equipment, processes, and systems.
- Document test activities and results in accordance with approved protocols.
- Identify, document, and support the resolution of deviations encountered during validation activities.
- Conduct risk assessments to identify potential hazards, failure modes, and critical points within equipment and processes.
- Support development of risk mitigation strategies and ensure alignment with applicable regulatory and quality requirements.
- Evaluate proposed changes to equipment, systems, and processes for potential impacts to validated status.
- Support change control activities and determine appropriate validation or requalification requirements.
- Prepare and maintain validation protocols, reports, SOPs, and supporting documentation.
- Compile validation results and prepare reports documenting test outcomes, deviations, and investigations.
- Ensure validation records are accurate, complete, traceable, and inspection-ready.
- Apply applicable Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and other relevant regulatory and industry requirements.
- Stay current with applicable validation guidance, standards, and regulatory expectations.
- Ensure validation activities are performed in accordance with approved procedures and quality systems.
- Partner with Engineering, Quality Assurance, Manufacturing, and other functional teams to plan and execute validation projects.
- Communicate project status, risks, issues, and results to key stakeholders.
- Build relationships across multiple manufacturing sites and functional organizations.
- Support ongoing monitoring of validated equipment, processes, and systems.
- Assist with periodic reviews and requalification activities to maintain a state of validated control.
- Ensure the integrity, accuracy, security, and traceability of data generated during validation activities.
- Support identification and prevention of data discrepancies.
- Where applicable, participate in Computer System Validation (CSV) activities for computerized systems.
- Provide training and guidance to personnel involved in validation activities.
- Identify opportunities to improve validation processes, procedures, and methodologies.
- Apply lessons learned and industry best practices to strengthen validation practices across the organization.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
