CQV Engineer
2 weeks 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.
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Engineer II, Validation
4 weeks ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleIn this role, you will perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. Reporting to the Validation Manager, CQV, the Engineer II will own the delivery of the capital projects, site re-qualification and periodic review programs, ensuring systems and...
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Engineer II, Validation
1 month ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleIn this role, you will perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. Reporting to the Validation Manager, CQV, the Engineer II will own the delivery of the capital projects, site re-qualification and periodic review programs, ensuring systems and...
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Sr. GxP Automation Engineer
1 month ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleAs 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 and...
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Sr. GxP Automation Engineer
4 weeks ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleAs 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 and...
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Sr. GxP Automation Engineer
4 weeks ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleAs 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 and...
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Sr. GxP Automation Engineer
1 month ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleAs 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 and...
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Associate Director, QA Operations, Drug Product
1 month ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleReporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance 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...
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Associate Director, QA Operations, Drug Product
4 weeks ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleReporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance 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...
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Sr. Manager, Validation, Drug Product
2 weeks 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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Engineer II, Validation
1 month ago
Norwood, United States Moderna, Inc. Full timeThe RoleIn this role, you will perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. Reporting to the Validation Manager, CQV, the Engineer II will own the delivery of the capital projects, site re-qualification and periodic review programs, ensuring systems and...
-
Engineer II, Validation
1 week ago
Norwood, United States Moderna Full timeThe Role In this role, you will perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. Reporting to the Validation Manager, CQV, the Engineer II will own the delivery of the capital projects, site re-qualification and periodic review programs, ensuring systems and...
-
Engineer II, Validation
1 week ago
Norwood, United States Moderna Full timeThe Role In this role, you will perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. Reporting to the Validation Manager, CQV, the Engineer II will own the delivery of the capital projects, site re-qualification and periodic review programs, ensuring systems and...
-
Engineer II, Validation
4 weeks ago
Norwood, United States Moderna, Inc. Full timeThe RoleIn this role, you will perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. Reporting to the Validation Manager, CQV, the Engineer II will own the delivery of the capital projects, site re-qualification and periodic review programs, ensuring systems and...
-
Engineer II, Validation
1 week ago
Norwood, United States Moderna Full timeThe Role In this role, you will perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. Reporting to the Validation Manager, CQV, the Engineer II will own the delivery of the capital projects, site re-qualification and periodic review programs, ensuring systems and...
-
Sr. GxP Automation Engineer
1 month ago
Norwood, United States Moderna, Inc. Full timeThe RoleAs 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 and...
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Sr. GxP Automation Engineer
4 weeks ago
Norwood, United States Moderna, Inc. Full timeThe RoleAs 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 and...
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Associate Director, QA Operations, Drug Product
1 month ago
Norwood, United States Moderna Theraputics Full timeThe Role Reporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance 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...
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Associate Director, QA Operations, Drug Product
2 weeks ago
Norwood, United States Moderna Theraputics Full timeThe Role Reporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance 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...
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Associate Director, QA Operations, Drug Product
4 weeks ago
Norwood, United States Moderna Theraputics Full timeThe Role Reporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance 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...
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Associate Director, QA Operations, Drug Product
1 month ago
Norwood, United States Moderna, Inc. Full timeThe RoleReporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance 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...
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Associate Director, QA Operations, Drug Product
1 month ago
Norwood, United States BioSpace Full timeJob DetailsThe RoleReporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance 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...
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Associate Director, QA Operations, Drug Product
1 month ago
Norwood, United States Moderna, Inc. Full timeThe RoleReporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance 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...
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Associate Director, QA Operations, Drug Product
4 weeks ago
Norwood, United States Moderna, Inc. Full timeThe RoleReporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance 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...
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Associate Director, QA Operations, Drug Product
4 weeks ago
Norwood, United States BioSpace Full timeJob DetailsThe RoleReporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance 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...
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Associate Director, QA Operations, Drug Product
4 weeks ago
Norwood, United States Moderna Full timeThe Role Reporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance 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...
-
Associate Director, QA Operations, Drug Product
4 weeks ago
Norwood, United States Moderna, Inc. Full timeThe RoleReporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance 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...
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Sr. Manager, Validation, Drug Product
2 weeks 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,...
