Manager, QA Validation Oversight
$90K - $173K/yr
We are seeking a Manager, QA Validation Oversight to lead a team dedicated to ensuring the integrity of our process validation processes. This role is integral in supporting process validation ...
$90K - $173K/yr
We are seeking a Manager, QA Validation Oversight to lead a team dedicated to ensuring the integrity of our process validation processes. This role is integral in supporting process validation ...
$90K - $173K/yr
We are seeking a Manager, QA Validation Oversight to lead a team dedicated to ensuring the integrity of our process validation processes. This role is integral in supporting process validation ...
Indianapolis, IN · On-site +1
$100K - $130K/yr
This position reports to the Process Validation Manager and is part of the Technical Operations Department located in Fargo, ND and will be fully remote. In this role, you will have the opportunity ...
Indianapolis, IN · On-site +1
$100K - $130K/yr
This position reports to the Process Validation Manager and is part of the Technical Operations Department located in Fargo, ND and will be fully remote. In this role, you will have the opportunity ...
Indianapolis, IN · On-site +1
$100K - $130K/yr
This position reports to the Process Validation Manager and is part of the Technical Operations Department located in Fargo, ND and will be fully remote. In this role, you will have the opportunity ...
Indianapolis, IN · On-site +1
$100K - $130K/yr
This position reports to the Process Validation Manager and is part of the Technical Operations Department located in Fargo, ND and will be fully remote. In this role, you will have the opportunity ...
Coordinate with the Integration Engineer on alarm management validation (ISA 18.2) and OT cybersecurity validation (ISA/IEC 62443). * Validate OPC/UA integration between Metasys, AVEVA PI, and DeltaV ...
Coordinate with the Integration Engineer on alarm management validation (ISA 18.2) and OT cybersecurity validation (ISA/IEC 62443). * Validate OPC/UA integration between Metasys, AVEVA PI, and DeltaV ...
Lead the Building Management System validation lifecycle across all buildings from User Requirement Specification authoring through Validation Summary Report and closeout. Author and obtain approval ...
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Lead the Building Management System validation lifecycle across all buildings from User Requirement Specification authoring through Validation Summary Report and closeout. Author and obtain approval ...
Lead the Building Management System validation lifecycle across all buildings from User Requirement Specification authoring through Validation Summary Report and closeout. Author and obtain approval ...
Lead the Building Management System validation lifecycle across all buildings from User Requirement Specification authoring through Validation Summary Report and closeout. Author and obtain approval ...
The Sterility Assurance Validation Associate I is responsible for the management and the execution of project and system qualifications, and validation confirmations including equipment and processes.
The Sterility Assurance Validation Associate I is responsible for the management and the execution of project and system qualifications, and validation confirmations including equipment and processes.
The Sterility Assurance Validation Associate I is responsible for the management and the execution of project and system qualifications, and validation confirmations including equipment and processes.
The Sterility Assurance Validation Associate I is responsible for the management and the execution of project and system qualifications, and validation confirmations including equipment and processes.
Noblesville, IN · On-site
Maintain and administer validation records within the company's quality management system, including documentation in Agile and other relevant tools. * Spend time on the manufacturing floor to ...
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Noblesville, IN · On-site
Maintain and administer validation records within the company's quality management system, including documentation in Agile and other relevant tools. * Spend time on the manufacturing floor to ...
Indianapolis, IN · On-site
Create, review, and manage validation documentation and qualification packages. * Ensure validation activities comply with GMP standards and regulatory requirements. * Utilize electronic validation ...
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Indianapolis, IN · On-site
Create, review, and manage validation documentation and qualification packages. * Ensure validation activities comply with GMP standards and regulatory requirements. * Utilize electronic validation ...
... management. - Support and lead continuous improvement activities through leadership, facilitation, and collaboration - Ensure all packaging validation activities are properly documented and ...
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... management. - Support and lead continuous improvement activities through leadership, facilitation, and collaboration - Ensure all packaging validation activities are properly documented and ...
Validation Engineering Roles Who You'll Work With Join one of our 45 offices in the US as part of a ... Project Management & Leadership : • Lead all aspects of client relationship development and ...
Validation Engineering Roles Who You'll Work With Join one of our 45 offices in the US as part of a ... Project Management & Leadership : • Lead all aspects of client relationship development and ...
Project Management & Leadership : Lead all aspects of client relationship development and project ... Validation Engineer II: Minimum2-7yearsproject experience with validation of automation, packaging ...
Project Management & Leadership : Lead all aspects of client relationship development and project ... Validation Engineer II: Minimum2-7yearsproject experience with validation of automation, packaging ...
The Validation Lead/Associate III, Commissioning Qualification, Validation is a strong individual ... This position reports to the Sr. Manager, Technical Services. Responsibilities: * Provide guidance ...
The Validation Lead/Associate III, Commissioning Qualification, Validation is a strong individual ... This position reports to the Sr. Manager, Technical Services. Responsibilities: * Provide guidance ...
Indianapolis, IN · On-site
Own and manage complex validation programs and ensure timely execution of protocols, reports, and lifecycle documentation. * Review and approve validation documents including SOPs, forms, protocols ...
Indianapolis, IN · On-site
Own and manage complex validation programs and ensure timely execution of protocols, reports, and lifecycle documentation. * Review and approve validation documents including SOPs, forms, protocols ...
Project Management & Leadership : Lead all aspects of client relationship development and project ... Validation Engineer II: Minimum2-7yearsproject experience with validation of automation, packaging ...
Project Management & Leadership : Lead all aspects of client relationship development and project ... Validation Engineer II: Minimum2-7yearsproject experience with validation of automation, packaging ...
Indianapolis, IN · Hybrid
$80K - $150K/hr
Support commissioning, qualification, and validation of new and existing equipment including ... Ability to work independently, manage priorities, and contribute in a fast-paced environment.
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Indianapolis, IN · Hybrid
$80K - $150K/hr
Support commissioning, qualification, and validation of new and existing equipment including ... Ability to work independently, manage priorities, and contribute in a fast-paced environment.
Indianapolis, IN · On-site
Own and manage complex validation programs and ensure timely execution of protocols, reports, and lifecycle documentation. * Review and approve validation documents including SOPs, forms, protocols ...
Indianapolis, IN · On-site
Own and manage complex validation programs and ensure timely execution of protocols, reports, and lifecycle documentation. * Review and approve validation documents including SOPs, forms, protocols ...
The Validation Lead/Associate III, Commissioning Qualification, Validation is a strong individual ... This position reports to the Sr. Manager, Technical Services. Responsibilities: * Provide guidance ...
The Validation Lead/Associate III, Commissioning Qualification, Validation is a strong individual ... This position reports to the Sr. Manager, Technical Services. Responsibilities: * Provide guidance ...
$82K - $99K/yr
Foundational understanding of validation principles, GMP requirements, and risk management concepts. * Strong attention to detail, organization, and willingness to learn. * Effective interpersonal ...
$82K - $99K/yr
Foundational understanding of validation principles, GMP requirements, and risk management concepts. * Strong attention to detail, organization, and willingness to learn. * Effective interpersonal ...
$45.2K - $55K
1% of jobs
$55K - $64.7K
4% of jobs
$72.9K is the 25th percentile. Wages below this are outliers.
$64.7K - $74.5K
24% of jobs
$74.5K - $84.3K
9% of jobs
The median wage is $91.3K / yr.
$84.3K - $94.1K
17% of jobs
$94.1K - $103.8K
8% of jobs
$103.8K - $113.6K
5% of jobs
$120.2K is the 75th percentile. Wages above this are outliers.
$113.6K - $123.4K
11% of jobs
$123.4K - $133.2K
8% of jobs
$133.2K - $142.9K
6% of jobs
$142.9K - $152.7K
8% of jobs
$45.2K
$100.3K
$152.7K
A validation manager works in a manufacturing plant and oversees the proper operation of machinery and equipment. Your job duties include developing operational plans for the entire facility, identifying areas of process improvement, and scheduling periodic auditing reviews of the facility. The qualifications needed for a career as a validation manager include a bachelor’s degree in business, organizational theory, quality control, or a related field. You also need strong communication and computer skills and experience in a management position.
| Aspect | Validation Manager | Quality Assurance Specialist |
|---|---|---|
| Certifications | GxP, ISO, or industry-specific validation certifications | ISO, Six Sigma, or QA-related certifications |
| Work Environment | Regulated industries like pharmaceuticals, biotech, or medical devices | Manufacturing, software, or service industries |
| Primary Focus | Ensuring validation processes for equipment, systems, and processes meet standards | Monitoring and improving overall quality processes and compliance |
The Validation Manager primarily oversees validation activities to ensure compliance with industry standards, focusing on equipment and process validation. In contrast, the Quality Assurance Specialist concentrates on maintaining overall quality standards across products and services. Both roles are essential for compliance but differ in scope and responsibilities.

$90K - $173K/yr
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 6 days ago
8.7
Based on 42 frontline employees who took The Breakroom Quiz
14th of 86 rated pharmaceutical
Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, QA Validation Oversight to lead a team dedicated to ensuring the integrity of our process validation processes. This role is integral in supporting process validation activities, ensuring global consistency, addressing recurring themes in process documentation, and playing a pivotal role in regulatory inspections and compliance.
When & where:
Location: Rensselaer, NY
Work model: Monday-Friday, 8am-4:30pm
Discover your role:
Ensuring alignment between validation activities and Process Sciences initiatives to support successful transition of processes from development to manufacturing.
Collaborate closely with internal Process Sciences team to provide technical expertise and ensure consistency in Process Validation strategies.
Presenting/defending validation strategies, documentation, and processes to FDA and other regulatory agencies.
Reviewing and approving process validation documents, procedures, and protocols, proposing modifications and corrections where necessary to meet regulatory requirements and expectations.
Overseeing all aspects of QA Validation including review and approval of failure investigations, change controls, SOPs, Validation protocols and summary reports, and validation master plans.
Conduct one-on-one discussions with team members to review their performance feedback and set development goals, fostering professional growth within the team.
This role requires:
Bachelor's degree in Engineering, Chemistry, or Life Sciences degree, or equivalent combination of education and experience, and the following amount of relevant work experience for each level:
Associate Manager: 6+ years
Manager: 7+ years
Level will be determined based on experience
Hands-on validation experience in a GMP-regulated environment
Deep understanding and expertise in Process Validation
Enjoying building strong, collaborative relationships across global internal teams
A continuous improvement mindset
Leadership skills that inspires and guides a multi-tiered team
#REGNQA
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$90,800.00 - $173,400.00Get the full story on Breakroom
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Biotechnology research and development
5,001 - 10,000 Employees
Tarrytown, NY, US
1988