BEPC Inc. - Business Excellence Professional Consulting
Validation Engineer (Medical Industry)
BEPC Inc. - Business Excellence Professional Consulting, Santa Clara, California, us, 95053
Position and Location
Santa Clara, CA
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Validation Engineer
BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.
Direct message the job poster from BEPC Inc. - Business Excellence Professional Consulting.
Base Pay Range $60.00/hr – $65.00/hr
Key Responsibilities
Strong knowledge and experience in generating equipment and fixture matrices for MVP, with qualification requirements defined by the medical device company.
Create detailed and specific IQ/OQ validation protocols for medical device manufacturing and laboratory settings in accordance with client requirements and standards.
Execute detailed, technical IQ/OQ validation protocols for medical device manufacturing and laboratory settings, in line with client requirements and standards.
Upon successful completion of IQ/OQ validations, author validation completion reports.
Execute detailed and technical PQ validations as per client requirements and standards.
Successful completion of PQ validations and author validation completion reports.
Provide technical expertise and support to develop and implement all associated Standard Operating Procedures for newly validated medical device processes and laboratory equipment.
Demonstrate experience in troubleshooting, root cause analysis, problem‑solving, implementing effective corrective actions, and following GMP requirements to ensure compliance with all medical device regulations.
Manage multiple complex validation projects on laboratory equipment simultaneously, from start to finish. Capable of handling all aspects of validation work, including the creation of IQ, OQ, and PQ documents.
Qualifications
Degree level in Science/Engineering field.
Minimum 3+ years of experience as a Validation Engineer within a medical device, pharmaceutical, or similar regulated industry.
Experience in aspects of Validation and ISO 13485 with proven knowledge of FDA and MDD GMP requirements regarding medical devices or pharma.
Must be able to speak, comprehend, and write English. level (reading and writing) with basic conversation skills.
Desirable
GD&T and Statistical Engineering Qualification.
--This role is not offered on a C2C basis, and candidates under this arrangement will not be considered-- Seniority Level Associate
Employment Type Contract
Job Function Engineering, Manufacturing, and Consulting
Industries Manufacturing, Engineering Services, and Medical Equipment Manufacturing
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–
Validation Engineer
BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.
Direct message the job poster from BEPC Inc. - Business Excellence Professional Consulting.
Base Pay Range $60.00/hr – $65.00/hr
Key Responsibilities
Strong knowledge and experience in generating equipment and fixture matrices for MVP, with qualification requirements defined by the medical device company.
Create detailed and specific IQ/OQ validation protocols for medical device manufacturing and laboratory settings in accordance with client requirements and standards.
Execute detailed, technical IQ/OQ validation protocols for medical device manufacturing and laboratory settings, in line with client requirements and standards.
Upon successful completion of IQ/OQ validations, author validation completion reports.
Execute detailed and technical PQ validations as per client requirements and standards.
Successful completion of PQ validations and author validation completion reports.
Provide technical expertise and support to develop and implement all associated Standard Operating Procedures for newly validated medical device processes and laboratory equipment.
Demonstrate experience in troubleshooting, root cause analysis, problem‑solving, implementing effective corrective actions, and following GMP requirements to ensure compliance with all medical device regulations.
Manage multiple complex validation projects on laboratory equipment simultaneously, from start to finish. Capable of handling all aspects of validation work, including the creation of IQ, OQ, and PQ documents.
Qualifications
Degree level in Science/Engineering field.
Minimum 3+ years of experience as a Validation Engineer within a medical device, pharmaceutical, or similar regulated industry.
Experience in aspects of Validation and ISO 13485 with proven knowledge of FDA and MDD GMP requirements regarding medical devices or pharma.
Must be able to speak, comprehend, and write English. level (reading and writing) with basic conversation skills.
Desirable
GD&T and Statistical Engineering Qualification.
--This role is not offered on a C2C basis, and candidates under this arrangement will not be considered-- Seniority Level Associate
Employment Type Contract
Job Function Engineering, Manufacturing, and Consulting
Industries Manufacturing, Engineering Services, and Medical Equipment Manufacturing
#J-18808-Ljbffr