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Validation Engineer

Lancesoft

Middletown, VA

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JOB DETAILS
SALARY
$65
SKILLS
Biology, Biotech and Pharmaceutical, Calibration, Change Control, Code of Federal Regulations, Communication Skills, Continuous Improvement, Corrective Action, Cross-Functional, Data Analysis, Detail Oriented, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), ISO (International Organization for Standardization), Leadership, Maintain Compliance, Manufacturing, Medical Equipment, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Multitasking, Network Connectivity, Organizational Skills, Presentation/Verbal Skills, Process Development, Process Improvement, Process Validation, Production Systems, Project Planning, Quality Engineering, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Risk, Risk Analysis, Root Cause Analysis, System Validation, Team Player, Technical Writing, Time Management, Validation Documentation, Validation Plan, Writing Skills
LOCATION
Middletown, VA
POSTED
8 days ago
Shift: 1st shift, Mon-Friday
Duration: 09 Months, Temp to Perm Opportunity
Pay range: $65.00- $65.00 Hourly
100% Onsite job
  • The 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
Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:
  • Four options of medical Insurance
  • Dental and Vision Insurance
  • 401k Contributions
  • Critical Illness Insurance
  • Voluntary Permanent Life Insurance
  • Accident Insurance
  • Other Employee Perks
About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.     

About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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