Associate Validation Engineer Reporting to the Quality Assurance (QA) Manager or equivalent manager ... Customer service and project management experience desired. * ISO 9000 experience a plus.
Associate Validation Engineer Reporting to the Quality Assurance (QA) Manager or equivalent manager ... Customer service and project management experience desired. * ISO 9000 experience a plus.
Associate Validation Engineer Reporting to the Quality Assurance (QA) Manager or equivalent manager ... Customer service and project management experience desired. * ISO 9000 experience a plus.
Associate Validation Engineer Reporting to the Quality Assurance (QA) Manager or equivalent manager ... Customer service and project management experience desired. * ISO 9000 experience a plus.
As a Controls Project Manager, you will be responsible for project financials, administration ... Must possess a valid driver's license for a minimum of 12 months, with no major or frequent traffic ...
As a Controls Project Manager, you will be responsible for project financials, administration ... Must possess a valid driver's license for a minimum of 12 months, with no major or frequent traffic ...
As a Controls Project Manager, you will be responsible for project financials, administration ... Must possess a valid driver's license for a minimum of 12 months, with no major or frequent traffic ...
As a Controls Project Manager, you will be responsible for project financials, administration ... Must possess a valid driver's license for a minimum of 12 months, with no major or frequent traffic ...
Validation Manager - Project Based
Mendon, UT ยท On-site
$103K - $136K/yr
... project completion (typically 2-4 years), though scope and duration are driven by business needs. About the Role We are seeking a Validation Manager to lead the validation of our cutting-edge ...
Quick apply
Validation Manager - Project Based
Mendon, UT ยท On-site
$103K - $136K/yr
... project completion (typically 2-4 years), though scope and duration are driven by business needs. About the Role We are seeking a Validation Manager to lead the validation of our cutting-edge ...
Validation Manager - Project Based
Mendon, UT ยท On-site
$103K - $136K/yr
... project completion (typically 2-4 years), though scope and duration are driven by business needs. About the Role We are seeking a Validation Manager to lead the validation of our cutting-edge ...
Validation Manager - Project Based
Mendon, UT ยท On-site
$103K - $136K/yr
... project completion (typically 2-4 years), though scope and duration are driven by business needs. About the Role We are seeking a Validation Manager to lead the validation of our cutting-edge ...
... project completion (typically 2-4 years), though scope and duration are driven by business needs. About the Role We are seeking a Validation Manager to lead the validation of our cutting-edge ...
... project completion (typically 2-4 years), though scope and duration are driven by business needs. About the Role We are seeking a Validation Manager to lead the validation of our cutting-edge ...
Architectural Project Manager
Salt Lake City, UT ยท On-site
$77K - $103K/yr
Assists senior management in developing and validating project scope and fee, budget, and scope of services during the marketing and contract development process. * Assists in preparing project ...
Architectural Project Manager
Salt Lake City, UT ยท On-site
$77K - $103K/yr
Assists senior management in developing and validating project scope and fee, budget, and scope of services during the marketing and contract development process. * Assists in preparing project ...
Run verification sessions to confirm client understanding of platform functionality and validate configuration accuracy before go-live. Project Operations * Manage concurrent implementation projects ...
Run verification sessions to confirm client understanding of platform functionality and validate configuration accuracy before go-live. Project Operations * Manage concurrent implementation projects ...
Interact with the customer to validate expectations are understood and met after, during and after project completion. * Provide oversight for third-party construction firms. * Manage project review ...
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Interact with the customer to validate expectations are understood and met after, during and after project completion. * Provide oversight for third-party construction firms. * Manage project review ...
Project Manager
Sandy, UT ยท On-site
Interact with the customer to validate expectations are understood and met before, during and after project completion. * Provide oversight for third-party construction firms. * Manage project review ...
Project Manager
Sandy, UT ยท On-site
Interact with the customer to validate expectations are understood and met before, during and after project completion. * Provide oversight for third-party construction firms. * Manage project review ...
Project Manager
Salt Lake City, UT ยท On-site
Project Manager ID: 8504 Department: Dacon Location: Salt Lake City, UT Description DACON, the ... Review and validate estimate assumptions, exclusions, and clarifications; participate in the bid ...
Project Manager
Salt Lake City, UT ยท On-site
Project Manager ID: 8504 Department: Dacon Location: Salt Lake City, UT Description DACON, the ... Review and validate estimate assumptions, exclusions, and clarifications; participate in the bid ...
Project Manager
Sandy, UT ยท On-site
Interact with the customer to validate expectations are understood and met before, during and after project completion. * Provide oversight for third-party construction firms. * Manage project review ...
Project Manager
Sandy, UT ยท On-site
Interact with the customer to validate expectations are understood and met before, during and after project completion. * Provide oversight for third-party construction firms. * Manage project review ...
... Develop and validate the customer's business case. * Develop proposal, estimate, high level ... Strong Project Management background. * Team leadership and facilitation skills. * Proficiency in ...
... Develop and validate the customer's business case. * Develop proposal, estimate, high level ... Strong Project Management background. * Team leadership and facilitation skills. * Proficiency in ...
Project Manager
Salt Lake City, UT ยท On-site
... Develop and validate the customer's business case. * Develop proposal, estimate, high level ... Strong Project Management background. * Team leadership and facilitation skills. * Proficiency in ...
Project Manager
Salt Lake City, UT ยท On-site
... Develop and validate the customer's business case. * Develop proposal, estimate, high level ... Strong Project Management background. * Team leadership and facilitation skills. * Proficiency in ...
Project Manager
Layton, UT ยท On-site
The Project Manager works closely with engineers, technicians, estimators, and clients to keep ... Valid driver's license * Ability to pass a criminal background and MVR (driving record) screening
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Project Manager
Layton, UT ยท On-site
The Project Manager works closely with engineers, technicians, estimators, and clients to keep ... Valid driver's license * Ability to pass a criminal background and MVR (driving record) screening
Project Manager
Salt Lake City, UT ยท Remote
$100K - $165K/yr
... Valid driver's license and willingness to travel by vehicle and/or airplane within service ... project management; experience with pipeline, compression, or other energy infrastructure EPC ...
Quick apply
Project Manager
Salt Lake City, UT ยท Remote
$100K - $165K/yr
... Valid driver's license and willingness to travel by vehicle and/or airplane within service ... project management; experience with pipeline, compression, or other energy infrastructure EPC ...
Project Manager
Salt Lake City, UT ยท On-site
Valid drivers license and acceptable driving record * Strong knowledge of project management principles, methodologies, and tools (e.g., MS Project, Smartsheet) * Excellent organizational skills with ...
Project Manager
Salt Lake City, UT ยท On-site
Valid drivers license and acceptable driving record * Strong knowledge of project management principles, methodologies, and tools (e.g., MS Project, Smartsheet) * Excellent organizational skills with ...
Valid drivers license and acceptable driving record * Strong knowledge of project management principles, methodologies, and tools (e.g., MS Project, Smartsheet) * Excellent organizational skills with ...
Valid drivers license and acceptable driving record * Strong knowledge of project management principles, methodologies, and tools (e.g., MS Project, Smartsheet) * Excellent organizational skills with ...
Project Manager
South Jordan, UT ยท On-site
Run verification sessions to confirm client understanding of platform functionality and validate configuration accuracy before go-live. Project Operations * Manage concurrent implementation projects ...
Project Manager
South Jordan, UT ยท On-site
Run verification sessions to confirm client understanding of platform functionality and validate configuration accuracy before go-live. Project Operations * Manage concurrent implementation projects ...
Validation Project Manager information
What is the highest paying project manager job?
How does a Validation Project Manager typically collaborate with cross-functional teams during a project?
Can I make 100k as a project manager?
What are the key skills and qualifications needed to thrive as a Validation Project Manager, and why are they important?
What are the 4 types of project managers?
What is a validation project manager?
What is the difference between Validation Project Manager vs Quality Assurance Specialist?
| Aspect | Validation Project Manager | Quality Assurance Specialist |
|---|---|---|
| Certifications | GMP, ISO, PMP | ISO, Six Sigma, GMP |
| Work Environment | Regulated industries like pharma, biotech | Manufacturing, software, healthcare |
| Primary Focus | Ensuring validation processes and protocols | Maintaining quality standards and procedures |
| Employer Usage | Pharmaceutical, biotech, medical device companies | Manufacturers, software firms, healthcare providers |
The Validation Project Manager primarily oversees validation activities, ensuring compliance with industry standards, while the Quality Assurance Specialist focuses on maintaining overall quality standards across processes. Both roles require similar certifications and are common in regulated industries, but their core responsibilities differ in scope and focus.
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Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 17 days ago
Job description
Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.
Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.
Associate Validation Engineer
Reporting to the Quality Assurance (QA) Manager or equivalent manager/supervisor, Associate Validation Engineer will provide management with information and data on all key aspects of each customer's validation project, which is used by both the plant and the customer to determine the course of routine processing. Must effectively interface with Sales, Operations, Corporate EO Technology, Laboratory (if any), EHS, Quality, Engineering and other Sterigenics' facilities, as well as customers and regulatory personnel.
Duties and Responsibilities
- Plans, organizes, and coordinates customer validation activities at the facility.
- Writes validation protocols and final reports supplied by the facility.
- Reviews and approves customer or consultant supplied validation or test protocols for execution within the limitation of the facility's equipment and Sterigenics operating procedures and compliance with current regulatory standards.
- Responsible for the execution of validation protocols and technically driven customer projects, which include but are not limited to the following:
- Scheduling the project runs, ancillary resources, lab testing and sample handling.
- Cycle programming and preparation of necessary process documents and safety assessments.
- Microbiological samples
- Data collection and analysis of temperature and humidity probe data
- Assuring proper handling, storage and shipping of bioburden, LALs, biological indicators, or residual samples to the appropriate laboratory
- Assures that all validation calibration activities are performed according to Sterigenics procedures and traceable to NIST.
- Provides support to Maintenance or Engineering in the performance of IQ/OQ/PQ activities of new or existing facility equipment.
- Responsible for annual equipment re-commissioning (sterilization and laboratory).
- Update validation status in the relevant systems.
- May be required to assist with corrective action and validation process improvement activities. Performs other duties as required to support the overall plant operation and quality system.
Supervision Given
- Does not supervise the work of others.
Education, Experience, & Skill Required
- Minimum BA or BS in a science related field (or international equivalent) and/or 4-6 years equivalent experience
- Two (2) to four (4) years of experience in the pharmaceutical, food or medical device industry with GMP/GLP knowledge a plus but not required.
- Direct experience in sterility assurance or products sterilization a plus but not required.
- Experience in writing and executing validation protocols preferred.
- Customer service and project management experience desired.
- ISO 9000 experience a plus.
- Excellent written and verbal communication skills.
- Strong computer skills.
- Forklift driving experience preferred, however internal training will be given.
- Must be able to lift a minimum of 50 lbs. (23kg) and perform repetitive bending and lifting motions over a period of time.
- Must be able to work a flexible schedule including weekends, holidays (if necessary).
- Must be able to travel 10-20% to various locations as needed.
Special Requirements
- Must possess a thorough understanding of US FDA Quality Systems Regulations, ISO 9000 regulations, and international regulatory requirements.
- Knowledge and experience working with the FDA and/or international requirements for medical devices is essential.
- Knowledge of regulatory affairs for FDA (or international equivalent) registered medical device or pharmaceutical manufacturer and direct experience with conducting or participating in FDA (or international equivalent) or supplier audits.
- Experience in document control to satisfy all ISO 9000 and FDA (or international equivalent) Quality System requirements.
- Must be medically approved for respirator use (EO).
- Must be able to tolerate exposure to high temperatures and high humidity [up to 130F (55C) and 65% RH for 20 minutes] (EO).
Special Requirements
- Must be medically approved for respirator use (EO)
- Must be able to tolerate exposure to high temperatures and high humidity (120F and 60% RH for 20 minutes) (EO)
Training Required
- Must complete all required training for validation internal certification.
Benefits
Sotera Health offers a competitive benefits package that includes:
- Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts
- 401(k) program with Company match that immediately vests
- Paid holidays, vacation and sick time
- Free financial planning assistance
- Paid parental leave
- Education assistance
- Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance
- Employee Assistance Program (EAP)
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics U.S. LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities. We strongly encourage those from underrepresented groups to apply.
VEVRAA Federal Contractor
Sotera Health goes to market through its three best-in-class businesses - Sterigenicsยฎ, Nordionยฎ and Nelson Labsยฎ. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.
About Sotera Health
Sourced by ZipRecruiter
Industry
Health care and social assistance
Company size
1,001 - 5,000 Employees
Headquarters location
Broadview Heights, OH, US
Year founded
2017