Validation Engineer

Pay Range: $55 to $65/Hour on W2

Position Summary
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
Bachelors degree in Engineering, Life Sciences, or related technical field required
02 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