BEPC Inc. - Business Excellence Professional Consulting
Validation Engineer I
BEPC Inc. - Business Excellence Professional Consulting, Santa Clara, California, us, 95053
BEPC has an open position for a Validation Engineer I.
Benefits: Medical, Dental, Vision, and Life Insurance.
Pay Rate: $60-$62 per hour (determined based on experience).
Term: 6-month contract with possible extensions.
Requirements: 1+ 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.
Note: This is a W2 only role — C2C, C2H will not be considered.
Seniority Level: Associate. Employment Type: Contract. Job Function: Manufacturing.
Responsibilities
Develop equipment and fixture matrices with defined qualification requirements in accordance with medical device regulations and client standards.
Prepare detailed and compliant Installation Qualification (IQ) and Operational Qualification (OQ) protocols for manufacturing and laboratory equipment.
Execute IQ/OQ protocols, ensuring accurate data collection, documentation integrity, and adherence to regulatory and client requirements.
Write and issue validation summary reports following the successful execution of IQ/OQ protocols.
Provide technical support for the development and implementation of Standard Operating Procedures (SOPs) related to newly qualified equipment and fixtures.
Perform troubleshooting, root cause analysis, and corrective action implementation to resolve validation and compliance issues.
Ensure all validation activities comply with FDA regulations, ISO 13485, GMP, and internal policies.
Manage multiple validation projects simultaneously, including documentation, scheduling, and communication with internal and client stakeholders.
Own and execute the full validation lifecycle for equipment and fixtures, from documentation development through testing and final reporting.
Qualifications
Bachelor’s degree in Engineering, Science, or a related technical field.
1 year of validation experience within a medical device, pharmaceutical, biotechnology, or similar regulated industry.
Knowledge of ISO 13485, FDA 21 CFR Part 820, Part 11, GMP, and GAMP standards related to equipment validation.
Must be able to speak, comprehend, and write English.
About BEPC BEPC Inc., founded in 2007, is a 100% employee‑owned company providing top‑tier consulting and staffing solutions across industries such as technology, engineering, manufacturing, and project management. BEPC is driven by innovation and a commitment to excellence, fostering a collaborative environment where employees thrive. Competitive benefits, including medical, dental, vision, and life insurance, support employees’ personal and professional growth.
Location Santa Clara, CA.
How to Apply Qualified candidates are encouraged to submit 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!
#J-18808-Ljbffr
Benefits: Medical, Dental, Vision, and Life Insurance.
Pay Rate: $60-$62 per hour (determined based on experience).
Term: 6-month contract with possible extensions.
Requirements: 1+ 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.
Note: This is a W2 only role — C2C, C2H will not be considered.
Seniority Level: Associate. Employment Type: Contract. Job Function: Manufacturing.
Responsibilities
Develop equipment and fixture matrices with defined qualification requirements in accordance with medical device regulations and client standards.
Prepare detailed and compliant Installation Qualification (IQ) and Operational Qualification (OQ) protocols for manufacturing and laboratory equipment.
Execute IQ/OQ protocols, ensuring accurate data collection, documentation integrity, and adherence to regulatory and client requirements.
Write and issue validation summary reports following the successful execution of IQ/OQ protocols.
Provide technical support for the development and implementation of Standard Operating Procedures (SOPs) related to newly qualified equipment and fixtures.
Perform troubleshooting, root cause analysis, and corrective action implementation to resolve validation and compliance issues.
Ensure all validation activities comply with FDA regulations, ISO 13485, GMP, and internal policies.
Manage multiple validation projects simultaneously, including documentation, scheduling, and communication with internal and client stakeholders.
Own and execute the full validation lifecycle for equipment and fixtures, from documentation development through testing and final reporting.
Qualifications
Bachelor’s degree in Engineering, Science, or a related technical field.
1 year of validation experience within a medical device, pharmaceutical, biotechnology, or similar regulated industry.
Knowledge of ISO 13485, FDA 21 CFR Part 820, Part 11, GMP, and GAMP standards related to equipment validation.
Must be able to speak, comprehend, and write English.
About BEPC BEPC Inc., founded in 2007, is a 100% employee‑owned company providing top‑tier consulting and staffing solutions across industries such as technology, engineering, manufacturing, and project management. BEPC is driven by innovation and a commitment to excellence, fostering a collaborative environment where employees thrive. Competitive benefits, including medical, dental, vision, and life insurance, support employees’ personal and professional growth.
Location Santa Clara, CA.
How to Apply Qualified candidates are encouraged to submit 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!
#J-18808-Ljbffr