cGxPServe
Validation Specialist – Lab Equipment Qualification
cGxPServe, Boston, Massachusetts, us, 02298
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Validation Specialist – Lab Equipment Qualification
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cGxPServe 2 days ago Be among the first 25 applicants Join to apply for the
Validation Specialist – Lab Equipment Qualification
role at
cGxPServe Get AI-powered advice on this job and more exclusive features. Perform qualification and validation of lab equipment (e.g., balances, incubators, autoclaves, HPLCs, TOCs, pH meters, etc.). Develop and execute equipment qualification protocols (IQ/OQ/PQ) in accordance with regulatory and company requirements. Perform impact and risk assessments for lab instruments and systems. Author and revise validation documents including Validation Plans, Protocols, Reports, SOPs, and User Requirements Specifications (URS).Support equipment lifecycle management and change control processes. Collaborate with cross-functional teams (QC, QA, IT, Engineering) to ensure validation project timelines and quality expectations are met. Participate in deviation investigations and CAPA related to equipment qualification failures or non-conformances. Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and applicable GAMP 5 guidelines. Maintain proper documentation and traceability in line with Data Integrity (ALCOA+) principles. Support regulatory inspections and internal audits related to lab equipment qualification.
Is this your next job Read the full description below to find out, and do not hesitate to make an application.
Responsibilities
Perform qualification and validation of lab equipment (e.g., balances, incubators, autoclaves, HPLCs, TOCs, pH meters, etc.). Develop and execute equipment qualification protocols (IQ/OQ/PQ) in accordance with regulatory and company requirements. Perform impact and risk assessments for lab instruments and systems. Author and revise validation documents including Validation Plans, Protocols, Reports, SOPs, and User Requirements Specifications (URS).Support equipment lifecycle management and change control processes. Review vendor-supplied documentation (FAT/SAT protocols, manuals, calibration certificates, etc.). Collaborate with cross-functional teams (QC, QA, IT, Engineering) to ensure validation project timelines and quality expectations are met. Participate in deviation investigations and CAPA related to equipment qualification failures or non-conformances. Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and applicable GAMP 5 guidelines. Maintain proper documentation and traceability in line with Data Integrity (ALCOA+) principles. Support regulatory inspections and internal audits related to lab equipment qualification.
Requirements:
Bachelor's degree in engineering, Life Sciences, Chemistry, or a related technical field. 3 7 years of experience in equipment qualification/validation in a GMP-regulated pharmaceutical, biotech, or medical device environment. Strong hands-on experience with qualification of lab instruments and computerized systems. Proficiency with validation lifecycle documents (IQ/OQ/PQ) and quality systems. Experience with cGMP, FDA, ICH Q8 Q10, GAMP 5, and 21 CFR Part 11 compliance. Strong technical writing and documentation skills. Ability to work independently and manage multiple priorities. Experience with validation software tools such as Val Genesis, Knead, or Track Wise. Familiarity with data integrity assessments and ALCOA+ principles. Experience supporting regulatory audits (FDA, EMA, etc.). Knowledge of analytical laboratory workflows. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesResearch Services Referrals increase your chances of interviewing at cGxPServe by 2x Get notified about new Validation Specialist jobs in
Boston, MA . Senior Quality Specialist, Vendor Quality Management Cambridge, MA $67,151.00-$79,460.00 1 week ago Quality of Life Specialist - $27, M-F 2pm-10pm, $500 Bonus (Vincent)Senior Validation Specialist- Computer System Validation Boston, MA $102,100.00-$111,700.00 3 days ago Sr Quality Specialist, Vendor Quality ManagementEquipment Validation Engineer(Contract) 22222 Waltham, MA $72,800.00-$80,100.00 3 days ago Sr. Quality Assurance Specialist, Plant Operations We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Validation Specialist – Lab Equipment Qualification
role at
cGxPServe 2 days ago Be among the first 25 applicants Join to apply for the
Validation Specialist – Lab Equipment Qualification
role at
cGxPServe Get AI-powered advice on this job and more exclusive features. Perform qualification and validation of lab equipment (e.g., balances, incubators, autoclaves, HPLCs, TOCs, pH meters, etc.). Develop and execute equipment qualification protocols (IQ/OQ/PQ) in accordance with regulatory and company requirements. Perform impact and risk assessments for lab instruments and systems. Author and revise validation documents including Validation Plans, Protocols, Reports, SOPs, and User Requirements Specifications (URS).Support equipment lifecycle management and change control processes. Collaborate with cross-functional teams (QC, QA, IT, Engineering) to ensure validation project timelines and quality expectations are met. Participate in deviation investigations and CAPA related to equipment qualification failures or non-conformances. Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and applicable GAMP 5 guidelines. Maintain proper documentation and traceability in line with Data Integrity (ALCOA+) principles. Support regulatory inspections and internal audits related to lab equipment qualification.
Is this your next job Read the full description below to find out, and do not hesitate to make an application.
Responsibilities
Perform qualification and validation of lab equipment (e.g., balances, incubators, autoclaves, HPLCs, TOCs, pH meters, etc.). Develop and execute equipment qualification protocols (IQ/OQ/PQ) in accordance with regulatory and company requirements. Perform impact and risk assessments for lab instruments and systems. Author and revise validation documents including Validation Plans, Protocols, Reports, SOPs, and User Requirements Specifications (URS).Support equipment lifecycle management and change control processes. Review vendor-supplied documentation (FAT/SAT protocols, manuals, calibration certificates, etc.). Collaborate with cross-functional teams (QC, QA, IT, Engineering) to ensure validation project timelines and quality expectations are met. Participate in deviation investigations and CAPA related to equipment qualification failures or non-conformances. Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and applicable GAMP 5 guidelines. Maintain proper documentation and traceability in line with Data Integrity (ALCOA+) principles. Support regulatory inspections and internal audits related to lab equipment qualification.
Requirements:
Bachelor's degree in engineering, Life Sciences, Chemistry, or a related technical field. 3 7 years of experience in equipment qualification/validation in a GMP-regulated pharmaceutical, biotech, or medical device environment. Strong hands-on experience with qualification of lab instruments and computerized systems. Proficiency with validation lifecycle documents (IQ/OQ/PQ) and quality systems. Experience with cGMP, FDA, ICH Q8 Q10, GAMP 5, and 21 CFR Part 11 compliance. Strong technical writing and documentation skills. Ability to work independently and manage multiple priorities. Experience with validation software tools such as Val Genesis, Knead, or Track Wise. Familiarity with data integrity assessments and ALCOA+ principles. Experience supporting regulatory audits (FDA, EMA, etc.). Knowledge of analytical laboratory workflows. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesResearch Services Referrals increase your chances of interviewing at cGxPServe by 2x Get notified about new Validation Specialist jobs in
Boston, MA . Senior Quality Specialist, Vendor Quality Management Cambridge, MA $67,151.00-$79,460.00 1 week ago Quality of Life Specialist - $27, M-F 2pm-10pm, $500 Bonus (Vincent)Senior Validation Specialist- Computer System Validation Boston, MA $102,100.00-$111,700.00 3 days ago Sr Quality Specialist, Vendor Quality ManagementEquipment Validation Engineer(Contract) 22222 Waltham, MA $72,800.00-$80,100.00 3 days ago Sr. Quality Assurance Specialist, Plant Operations We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr