Validation Engineer
Listed on 2025-12-15
-
Engineering
Quality Engineering, Biomedical Engineer, Validation Engineer, Pharma Engineer
BEPC Inc.
- Business Excellence Professional Consulting provided pay range
This range is provided by BEPC Inc.
- Business Excellence Professional Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
$60.00/hr - $65.00/hr
Direct message the job poster from BEPC Inc.
- Business Excellence Professional Consulting
BEPC has an open position for a Validation Engineer
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.
** BEPC does not accept C2C, C2H, or W2 referral applications. **
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.
- 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
.
- 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.
- 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
BEPC Inc., founded in 2007, is a 100% employee‑owned company providing top‑tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees’ personal and professional growth.
ApplyNow!
Qualified candidates are encouraged to apply by submitting an up‑to‑date resume that highlights how your experience aligns with the role. Please include specific examples that demonstrate your qualifications. We look forward to connecting with you!
Seniority levelAssociate
Employment typeContract
Job functionManufacturing and Consulting
IndustriesManufacturing and Business Consulting and Services
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