BEPC Inc. - Business Excellence Professional Consulting
Validation Engineer
BEPC Inc. - Business Excellence Professional Consulting, Santa Clara, California, us, 95053
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.
Base pay range $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. **
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.
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
About BEPC 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.
Apply Now! 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 level Associate
Employment type Contract
Job function Manufacturing and Consulting
Industries Manufacturing and Business Consulting and Services
#J-18808-Ljbffr
Base pay range $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. **
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.
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
About BEPC 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.
Apply Now! 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 level Associate
Employment type Contract
Job function Manufacturing and Consulting
Industries Manufacturing and Business Consulting and Services
#J-18808-Ljbffr