Validation Engineer

BEPC has an open position for a Validation Engineer

Location: Santa Clara, CA

Benefits: Medical, Dental, Vision, and Life Insurance

Pay Rate: $60-$65 per hour (Paid Weekly)

Term: 6-months contract with possible extensions

Requirements: 3+ years
of experience as a Validation Engineer in a
medical device, pharmaceutical, or similarly regulated
industry.

Experience with
Validation
and
ISO 13485
, with demonstrated knowledge of
FDA
and
MDD GMP
requirements related to Medical Devices or Pharm.

**NO CORP-TO-CORP CANDIDATES WILL BE CONSIDERED**

**BEPC does not accept C2C, C2H, or W2 referral applications. **

Job Description:

Position Duties & Responsibilities

• Generate
  equipment and fixture matrices
  for
  MVP
  , including qualification requirements as defined by the medical device company.
• Create detailed
  IQ/OQ validation protocols
  for medical device manufacturing and laboratory settings in accordance with client requirements and standards.
• Execute detailed and technical
  IQ/OQ validation protocols
  aligned with client requirements and applicable standards.
• Author
  validation completion reports
  upon successful IQ/OQ completion.
• Execute detailed and technical
  PQ validations
  per client requirements and standards.
• Author
  PQ validation completion reports
  upon successful completion.
• Provide technical expertise to develop and implement
  Standard Operating Procedures (SOPs)
  for newly validated processes and laboratory equipment.
• Troubleshoot issues using
  root cause analysis
  , structured problem-solving, and implement effective
  corrective actions (CAPA)
  while following
  GMP
  requirements.
• Ensure compliance with relevant medical device/pharma regulations and quality systems.
• Manage multiple complex validation projects simultaneously from initiation through completion.
• Independently handle all aspects of validation documentation and execution, including development of
  IQ, OQ, and PQ
  documentation.

Education & Experience Requirements:

• Bachelor's degree (or higher)
  in a Science or Engineering discipline.
• 3+ years
  of experience as a Validation Engineer in a
  medical device, pharmaceutical, or similarly regulated
  industry.
• Experience with
  Validation
  and
  ISO 13485
  , with demonstrated knowledge of
  FDA
  and
  MDD GMP
  requirements related to Medical Devices or Pharma.
• Must be able to
  speak, read, comprehend, and write English
  .

Desirable Qualifications

• Familiarity with
  J&J validation methodology
  .
• Knowledge of
  GD&T
  and
  Statistical Engineering Qualification
  .
• Experience with change documentation management using
  Adaptiv
  .
• Six Sigma Green Belt or Black Belt
  training/certification.

Key Skills & Competencies

• Validation lifecycle expertise (
  IQ/OQ/PQ
  ) and strong technical writing
• GMP mindset with compliance-focused execution
• Problem-solving, troubleshooting, and root cause analysis
• Strong organizational skills and ability to manage multiple projects
• Cross-functional collaboration and clear communication