CQV Engineer
2 months ago
- 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 assessment review and revalidation activities.
- Oversee external contractors and vendors during commissioning and qualification.
- Ensure deliverables are executed per Validation Master Plan and other required SOPs.
- Ensure discrepancies are resolved and closed out in a timely manner.
- Develop testing templates and qualification protocols using paper and electronic validation systems (Kneat)
- Perform system impact assessments, risk assessments, and traceability matrices.
- Support development of engineering lifecycle documents for new equipment
- Maintain the Validation Master Plan, engineering lifecycle documents, and validation program SOPs.
- Support site capital projects and other improvement projects
- Promotes engineering best practices, and cGMP regulations.
- Work with Quality Assurance to ensure all validation activities are in compliance.
- Support and execute Change Controls to qualified facilities, equipment, and utilities.
- A minimum of 8 years of experience in biotech engineering or an FDA regulated manufacturing facility.
- BS degree in engineering field or equivalent experience
- Experience in cGMP facility/equipment start-up, commissioning, and qualification
- Strong understanding of ASTM E2500 standards for commissioning, validation, and lifecycle management of GMP equipment and systems and GxP laboratories
- Required experience with good documentation practices and cGMP standards.
- Ability to work on multiple tasks simultaneously.
- Ability to manage priorities, deliverables, and schedule milestones.
- Requires strong interpersonal, verbal communication, and technical writing skills.
- Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.
-
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...
-
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...
-
Norwood, United States Randstad Life Sciences US Full timeEngineer 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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
Sr. GxP Automation Engineer
7 days ago
Norwood, United States Moderna Full timeThe Role As a Senior GxP Automation Engineer at Moderna, you will play a crucial part of our manufacturing operations, supporting the operation of our cutting-edge Drug Product (Fill Finish) GxP manufacturing systems. These systems include, but are not limited to Allen Bradley PLCs, Siemens PLCs, Wonderware System Platform, AVEVA Historian, Apprentice MES...
-
Project Planning Specialist
2 weeks ago
Norwood, Massachusetts, United States Flexible & Integrated Technical Services, LLC Full timeJob OverviewWe are seeking a skilled Project Scheduler to provide scheduling services within our Capital Projects division.Key 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 industry, preferably in Pharma or Biotech.Excellent...
-
Project Planning Specialist
1 week ago
Norwood, Massachusetts, United States Flexible & Integrated Technical Services, LLC Full timeJob OverviewWe are seeking a dedicated professional for scheduling services within our Capital Projects division.Key Qualifications:Educational Background: A Bachelor's Degree in Engineering or a related discipline is required, along with a minimum of five (5) years of scheduling experience in a regulated environment, preferably in Pharma or...
-
Project Management Scheduler
2 weeks ago
Norwood, Massachusetts, United States Flexible & Integrated Technical Services, LLC Full timeJob OverviewWe are seeking a skilled Project Scheduler to provide scheduling services within our Capital Projects division.Qualifications:The Technical Requirements:A Bachelor's Degree in Engineering or a related discipline is essential, along with a minimum of five (5) years of scheduling experience in a regulated industry, preferably in Pharma or...
-
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 our Capital Projects division.Ideal Candidate Profile:Technical Qualifications: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).Strong communication...
-
Project Management Scheduler
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.KEY 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).Strong Communication...