MillenniumSoft Inc
Validation Engineer Exp with biological equipment validation exp min 5 yrs of pu
MillenniumSoft Inc, San Diego, California, United States, 92189
Validation Engineer Exp with biological equipment validation exp min 5 yrs of pure validation Onsite
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Validation Engineer with biological equipment validation experience, minimum 5 years of pure validation, onsite
role at
MillenniumSoft Inc . Position Details
Title:
Validation Engineer - Biological Equipment Validation (Min 5 Years) Location:
San Diego, CA Duration:
12 Months Hours/week:
40 Shift:
1st Shift Client:
Medical Devices Company Category:
Engineering Experience Level:
Mid-Level Employment Type:
Contract on W2 (US Citizens, GC Holders, GC EAD, OPT, EAD, CPT) Job Description
The Validation Engineer is responsible for executing validation activities for manufacturing equipment and supporting process validation or verification studies, ensuring compliance with quality policies and regulatory standards. Responsibilities
Perform equipment and process validation studies, including protocol writing, data analysis, and reporting. Maintain and support biological equipment from a quality perspective, including preventive maintenance and calibration. Author and execute qualification protocols for analytical and manufacturing equipment. Validate GMP equipment across manufacturing facilities. Review and update risk management documents related to validation. Support manufacturing relocations and ensure business continuity. Assist in QA inspections and document reviews for product release. Qualifications
BSc in Biological Sciences, Chemistry, Bio-tech Engineering, or related field. 3-5 years of experience for QE II, 5-7 years for senior roles in medical device, biotech, or pharma industries. Skills and Knowledge
Excellent communication skills, knowledge of quality systems, statistical analysis (Minitab, Excel). Strong understanding of process and equipment validation, ISO 13485, ISO 9001, ISO 14971, and risk management. Experience with Six Sigma, SAP, and equipment management systems. Ability to work independently and in teams, organized, detail-oriented, self-motivated. Physical & Work Environment
Ability to work in controlled environments with laboratory equipment. Onsite presence required in manufacturing areas. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Referrals can increase interview chances. Get notifications for similar jobs in San Diego, CA.
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Join to apply for the
Validation Engineer with biological equipment validation experience, minimum 5 years of pure validation, onsite
role at
MillenniumSoft Inc . Position Details
Title:
Validation Engineer - Biological Equipment Validation (Min 5 Years) Location:
San Diego, CA Duration:
12 Months Hours/week:
40 Shift:
1st Shift Client:
Medical Devices Company Category:
Engineering Experience Level:
Mid-Level Employment Type:
Contract on W2 (US Citizens, GC Holders, GC EAD, OPT, EAD, CPT) Job Description
The Validation Engineer is responsible for executing validation activities for manufacturing equipment and supporting process validation or verification studies, ensuring compliance with quality policies and regulatory standards. Responsibilities
Perform equipment and process validation studies, including protocol writing, data analysis, and reporting. Maintain and support biological equipment from a quality perspective, including preventive maintenance and calibration. Author and execute qualification protocols for analytical and manufacturing equipment. Validate GMP equipment across manufacturing facilities. Review and update risk management documents related to validation. Support manufacturing relocations and ensure business continuity. Assist in QA inspections and document reviews for product release. Qualifications
BSc in Biological Sciences, Chemistry, Bio-tech Engineering, or related field. 3-5 years of experience for QE II, 5-7 years for senior roles in medical device, biotech, or pharma industries. Skills and Knowledge
Excellent communication skills, knowledge of quality systems, statistical analysis (Minitab, Excel). Strong understanding of process and equipment validation, ISO 13485, ISO 9001, ISO 14971, and risk management. Experience with Six Sigma, SAP, and equipment management systems. Ability to work independently and in teams, organized, detail-oriented, self-motivated. Physical & Work Environment
Ability to work in controlled environments with laboratory equipment. Onsite presence required in manufacturing areas. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Referrals can increase interview chances. Get notifications for similar jobs in San Diego, CA.
#J-18808-Ljbffr