Validation Engineer

Job Title: Validation Engineer
Location: Middletown, VA 22645
Duration: 9+ Months (Possible Extension)
 
Shift Time: Days
 
Job Description:
Intent to convert for quality workers if headcount is available.
The Entry-Level Validation Engineer will support execution of validation activities for the MDT Validation Remediation Project at the Middletown site. This role is project-specific and requires full onsite presence to support equipment, process, and system validation activities.
The engineer will assist in development, execution, and documentation of validation protocols and reports while ensuring alignment with regulatory and site requirements. The role includes supporting periodic reviews and conducting gap assessments to ensure continued compliance with validation standards and site procedures.
This position works under the guidance of senior validation engineers and project leadership.
 
Key Responsibilities:

• Support execution of validation master plans for project-specific equipment, systems, and processes.
• Author, revise, and execute validation protocols (IQ, OQ, PQ) and associated reports under supervision.
• Participate in periodic validation reviews and gap assessments to ensure ongoing compliance with regulatory and site standards.
• Assist in identifying validation gaps and support development of remediation plans.
• Analyze validation data to verify systems and processes meet defined acceptance criteria.
• Collaborate cross-functionally with Engineering, Quality, Manufacturing, and other departments to coordinate validation activities.
• Support deviation investigations, root cause analysis, and implementation of corrective actions.
• Maintain validation documentation in accordance with site quality systems.
• Support change control activities related to validated systems.
• Assist in calibration coordination and verification activities.
• Contribute to continuous improvement initiatives and identification of process optimization opportunities.
• Perform other project-related duties as assigned.

 
Minimum Requirements / Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related technical field required.
• 0–2 years of experience in validation, quality, engineering, or manufacturing within a regulated industry (Medical Device or Pharmaceutical preferred).
• Internship, co-op, or academic project experience in a regulated environment is acceptable.

 
Knowledge & Skills:

• Basic knowledge or exposure to:
  • FDA-regulated environments.
  • Quality standards (e.g., 21 CFR Part 820, ISO 13485).
  • Risk-based validation concepts.
  • Quality tools (FMEA, Risk Analysis, Root Cause Analysis).
  • Validation lifecycle documentation (IQ/OQ/PQ).
  • Electronic quality systems (e.g., Blue Mountain, MasterControl, SAP – preferred but not required).
• Proficient in:
  • Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).
  • Technical writing and documentation practices.

 
Personal Attributes:

• Strong written and verbal communication skills.
• Detail-oriented with strong organizational skills.
• Ability to work effectively in a team-based, cross-functional environment.
• Willingness to learn validation standards and regulatory requirements.
• Ability to manage multiple tasks within a structured project timeline.
• Comfortable working onsite in a manufacturing/production environment.