CQV (Commissioning, Qualification, and Validation) Engineer
3 weeks ago
Engineer I, CQV, Laboratory Compliance, Clinical Biomarker Laboratory 6 Month Contract 100% Onsite in Norwood, MA *W2 ONLY NO C2C OR 3rd Party* Pay Rate: $50PH MUST HAVE: Experience in GCLP/GLP or CLIA/CAP environment. Experience with the qualification of Lab equipment & Lab instruments Will be managing a large amount of paperwork through the system and driving the qualification process Summary The Engineer I, CQV (Commissioning, Qualification, and Validation) will be responsible for delivering commissioning, qualification, and validation activities ensuring equipment and systems remain in a qualified operational state of compliance within a GCLP/GLP Laboratory environment. This individual will collaborate closely with Lab Operations, Lab Compliance and R&D Quality to complete qualification activities. The ideal candidate enjoys working in a fast-paced, dynamic, and innovative environment. Responsibilities Execute commissioning, qualification, and validation activities to maintain compliance with GCLP guidelines and GLP regulations. Author and execute design, commissioning, qualification, and validation documentation and support records to certify compliance with specifications and procedures. Ensure timely resolution of documentation compliance and quality system issues. Investigate deviations related to qualification and validation activities Participate in cross-functional teams to meet project timelines and business needs while adhering to regulatory requirements. Ensure Standard Operating Procedures (SOPs) and procedures are created, understood, and followed. Participate in XXX training to support CQV requirements. Education & Qualifications B.S. in engineering, science, or an equivalent technical field. Minimum of one (1) year of relevant experience in a GCLP/GLP environment is desirable. Understanding of commissioning, qualification, and validation principles. Strong technical documentation generation and review skills, ensuring content is technically sound and adheres to applicable site procedures. Ability to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Excellent interpersonal and communication skills (verbal and written), with the ability to present work to peers and cross-functional managers and influence leadership decisions. Ability to interact well with other groups and take ownership of and follow through on assignments. Ability to represent the company's interests, objectives, and policies in a professional and responsible manner. Meticulous attention to detail, organizational ability, clinical judgment, and good communication skills. High proficiency in MS PowerPoint and MS Project, excellent writing skills, organizational skills, and attention to detail. A desire to make an impact as part of a high-growth, transformational company
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Norwood, United States Randstad Life Sciences US Full timeEngineer I, CQV, Laboratory Compliance, Clinical Biomarker Laboratory6 Month Contract 100% Onsite in Norwood, MA*W2 ONLY NO C2C OR 3rd Party*Pay Rate: $50PH MUST HAVE:Experience in GCLP/GLP or CLIA/CAP environment. Experience with the qualification of Lab equipment & Lab instrumentsWill be managing a large amount of paperwork through the system and driving...
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Norwood, United States Randstad Life Sciences US Full timeEngineer I, CQV, Laboratory Compliance, Clinical Biomarker Laboratory6 Month Contract 100% Onsite in Norwood, MA*W2 ONLY NO C2C OR 3rd Party*Pay Rate: $50PH MUST HAVE:Experience in GCLP/GLP or CLIA/CAP environment. Experience with the qualification of Lab equipment & Lab instrumentsWill be managing a large amount of paperwork through the system and driving...
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CQV Engineer
3 weeks ago
Norwood, United States Connexion Systems & Engineering, Inc. Full time $44 - $54Job DescriptionJob DescriptionJob Title: Engineer I, CQV, Laboratory Compliance, Clinical Biomarker LaboratoryLocation: Norwood MAPay: $44-54/hrEngineer I, CQV, Laboratory Compliance, Clinical Biomarker LaboratoryThe RoleThe Engineer I, CQV (Commissioning, Qualification, and Validation) will be responsible for delivering commissioning, qualification, and...
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CQV Engineer
1 month ago
Norwood, United States Connexion Systems & Engineering, Inc. Full timeJob DescriptionJob DescriptionJob Title: Engineer I, CQV, Laboratory Compliance, Clinical Biomarker LaboratoryLocation: Norwood MAPay: $44-54/hr Engineer I, CQV, Laboratory Compliance, Clinical Biomarker LaboratoryThe RoleThe Engineer I, CQV (Commissioning, Qualification, and Validation) will be responsible for delivering commissioning, qualification, and...
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CQV Engineer
3 weeks ago
Norwood, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Support qualification activities for facility and equipment Provide technical and validation support for capital projects on site working with facilities, and manufacturing, Quality Control and Quality Assurance (QA) teams. Lead validation activities and deliverables to meet the overall facility milestones. Lead and support...
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CQV Engineer
2 months ago
Norwood, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Support qualification activities for facility and equipment Provide technical and validation support for capital projects on site working with facilities, and manufacturing, Quality Control and Quality Assurance (QA) teams. Lead validation activities and deliverables to meet the overall facility milestones. Lead and support periodic...
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Engineer, Laboratory Compliance, Clinical Biomarker
2 months ago
Norwood, United States Randstad Life Sciences US Full timeEngineer, CQV, Laboratory Compliance, Clinical Biomarker$40-45 an hour6 months, onsite Norwood MAThe RoleThe Engineer I, CQV (Commissioning, Qualification, and Validation) will be responsible for delivering commissioning, qualification, and validation activities ensuring equipment and systems remain in a qualified operational state of compliance within a...
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Engineer, Laboratory Compliance, Clinical Biomarker
2 months ago
Norwood, United States Randstad Life Sciences US Full timeEngineer, CQV, Laboratory Compliance, Clinical Biomarker$40-45 an hour6 months, onsite Norwood MAThe RoleThe Engineer I, CQV (Commissioning, Qualification, and Validation) will be responsible for delivering commissioning, qualification, and validation activities ensuring equipment and systems remain in a qualified operational state of compliance within a...
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new york city (norwood), United States Randstad Life Sciences US Full timeEngineer, CQV, Laboratory Compliance, Clinical Biomarker$40-45 an hour6 months, onsite Norwood MAThe RoleThe Engineer I, CQV (Commissioning, Qualification, and Validation) will be responsible for delivering commissioning, qualification, and validation activities ensuring equipment and systems remain in a qualified operational state of compliance within a...
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new york city (norwood), United States Randstad Life Sciences US Full timeEngineer, CQV, Laboratory Compliance, Clinical Biomarker$40-45 an hour6 months, onsite Norwood MAThe RoleThe Engineer I, CQV (Commissioning, Qualification, and Validation) will be responsible for delivering commissioning, qualification, and validation activities ensuring equipment and systems remain in a qualified operational state of compliance within a...
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Project Planning Specialist
2 weeks ago
Norwood, Massachusetts, United States Flexible & Integrated Technical Services, LLC Full timeJob OverviewWe are seeking a dedicated Project Scheduler to provide scheduling services within our Capital Projects division.Key Qualifications:Technical Skills:Bachelor's Degree in Engineering or a related discipline with a minimum of five (5) years of scheduling experience in a regulated environment (Pharmaceutical/Biotech preferred).Fluency in both...
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Project Planning Specialist
2 weeks ago
Norwood, Massachusetts, United States Flexible & Integrated Technical Services, LLC Full timeJob OverviewWe are seeking a dedicated professional for Scheduling services within the Capital Projects sector.QUALIFICATIONS:Technical Requirements:Bachelor's Degree in Engineering or a related discipline, with a minimum of five (5) years of scheduling experience in a regulated environment (Pharmaceutical/Biotech preferred).Fully bilingual.Excellent...
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Network Qualification Engineer
3 weeks ago
Norwood, United States TEKsystems Full timeDescription: This Network Engineer will be supporting our client's Norwood manufacturing site. The ideal candidate will have extensive experience in a manufacturing environment and possess strong documentation skills. This role involves qualifying network systems, ensuring they meet industry standards, and supporting the seamless operation of our...
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Sr. Manager, Validation, Drug Product
3 months ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleReporting to the Associate Director, Validation the Sr. Manager, Validation is responsible for leading Validation readiness for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role involves ensuring operational readiness for production of both clinical and commercial drug products while adhering to current GxP,...
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Sr. Manager, Validation, Drug Product
3 months ago
Norwood, United States Moderna, Inc. Full timeThe RoleReporting to the Associate Director, Validation the Sr. Manager, Validation is responsible for leading Validation readiness for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role involves ensuring operational readiness for production of both clinical and commercial drug products while adhering to current GxP,...
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Network Qualification Engineer
2 weeks ago
Norwood, United States TEKsystems Careers Full time*Description:* This Network Engineer will be supporting the Client's Norwood manufacturing site. The ideal candidate will have extensive experience in a manufacturing environment and possess strong documentation skills. This role involves qualifying network systems, ensuring they meet industry standards, and supporting the seamless operation of our...
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Project Scheduler
1 month ago
Norwood, United States Flexible & Integrated Technical Services, LLC Full timeJob DescriptionJob Description For Scheduling services in the Capital Projects area. WHAT MAKES YOU A FIT: The Technical Part:Bachelor’s Degree in Engineering or a related field. A minimum of five (5) years of scheduling experience within the regulated industry (Pharma/Biotech preferred).Fully billingual Solid Communications SkillsShift: Administrative...
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Project Scheduler
1 month ago
Norwood, United States Flexible & Integrated Technical Services, LLC Full timeJob DescriptionJob Description For Scheduling services in the Capital Projects area. WHAT MAKES YOU A FIT: The Technical Part:Bachelor’s Degree in Engineering or a related field. A minimum of five (5) years of scheduling experience within the regulated industry (Pharma/Biotech preferred).Fully billingual Solid Communications SkillsShift: Administrative...
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Project Scheduler
4 weeks ago
Norwood, United States Flexible & Integrated Technical Services, LLC Full timeJob DescriptionJob Description For Scheduling services in the Capital Projects area. WHAT MAKES YOU A FIT: The Technical Part:Bachelor’s Degree in Engineering or a related field. A minimum of five (5) years of scheduling experience within the regulated industry (Pharma/Biotech preferred).Fully billingual Solid Communications SkillsShift: Administrative...
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Network Qualification Engineer
2 weeks ago
Norwood, United States TEKsystems Full timeDescription: This Network Engineer will be supporting the Client's Norwood manufacturing site. The ideal candidate will have extensive experience in a manufacturing environment and possess strong documentation skills. This role involves qualifying network systems, ensuring they meet industry standards, and supporting the seamless operation of our...
