Find work in the United States.

A simpler way to find your next job.

Jobs in the United States

25+ jobs

Save this search

Added just now
Software Engineer II - AI Platforms
Mastercard
Atlanta, GA
Mastercard is seeking a Software Engineer II to design, build, and enhance production-grade AI platform capabilities that enable AI-powered products and agentic experiences across B&MI.
Added just now
Senior Software Engineer - AI Platforms
Mastercard
Atlanta, GA
Mastercard is seeking a Senior Software Engineer to design and build production-grade AI platform capabilities that enable AI-powered products and agentic experiences across B&MI.
Added just now
Software Engineer II - AI Platforms
Mastercard
Atlanta, GA
Mastercard is seeking a Software Engineer II to design, build, and enhance production-grade AI platform capabilities that enable AI-powered products and agentic experiences across B&MI.
Added just now
AI Engineer ||
Mastercard
O Fallon, MO
The AI Engineer is responsible for designing and delivering AI-powered solutions that improve engineering productivity and business workflows. This role requires a strong foundation in…
Added just now
Associate Director Principal Engineer
AstraZeneca Pharmaceuticals LP Company
Mt. Vernon, IN
The Associate Director Principal Engineer is responsible providing technical support for process manufacturing, including investigation and correction of process-related problems and…
Added 1 min ago
Senior Automation Engineer
Novo Nordisk
Bloomington, IN
The Senior Automation Engineer (IT Automation) provides technical expertise in process automation and control systems, supporting site operations through the design, maintenance,…
Added 2 mins ago
Activations Manager, Startups
Vercel
NY · San Francisco, CA
Cross-Functional Collaboration: Partner with Marketing, Product, Growth, RevOps, Solutions Engineering, and the Greenfield and Install Base teams to make handoffs seamless as startups scale.
Added 2 mins ago
Senior Lead Software Engineer - Java, Prime Financial Services Technology
JPMC page
Jersey City, NJ
As a Senior Lead Software Engineer at JPMorganChase within the Commercial & Investment Technology in Cash Prime Technology, you are an integral part of an agile team that works to enhance,…
Added 2 mins ago
Data Scientist-Vice President-Finance Data & Analytics
JPMC page
Columbus, OH
Certification in cloud technologies (e.g., AWS Certified Solutions Architect, Azure Data Engineer)
Added 2 mins ago
Senior CMDB Architecture Engineer (R-19964)
Dun & Bradstreet
Jacksonville, FL
The Senior CMDB Architecture Engineer is responsible for the technical architecture, design, implementation, and ongoing health of the ServiceNow Configuration Management Database (CMDB).
Added 2 mins ago
Senior CMDB Architecture Engineer (R-19964)
Dun & Bradstreet
Center Valley, PA
The Senior CMDB Architecture Engineer is responsible for the technical architecture, design, implementation, and ongoing health of the ServiceNow Configuration Management Database (CMDB).
Added 2 mins ago
D&
Senior CMDB Architecture Engineer (R-19964)
Dun & Bradstreet
Florham Park, NJ
- $147,000 to $247,000 USD / year
The Senior CMDB Architecture Engineer is responsible for the technical architecture, design, implementation, and ongoing health of the ServiceNow Configuration Management Database (CMDB).
Added 3 mins ago
GS
Director Consulting
Geocomp Solutions Inc.
United States
- $145,000 to $165,000 USD / year
Professional Engineer (PE) license - Geotechnical or Geostructural background required
Added 3 mins ago
Senior Specialist, Quality Engineer
L3Harris Technologies
Camden, AR
L3Harris Technologies is seeking a Senior Specialist, Quality Engineer to join our growing facility in Camden, Arkansas. This role will be responsible for the design, development and…
Added 3 mins ago
IG
Sr. Automation Engineer
Insight Global
Fort Worth, TX
- $125,000 to $135,000 USD / year
· Bachelor of Science degree in Electrical Engineering, Electronics Engineering Technology, or relevant disciplines from an accredited University
Added 4 mins ago
Process Engineer
Team Member Services
United States
Knowledge of industrial engineering principles such as LEAN, workflow analysis, statistical analysis, work simplification, time standard, staffing analysis, and process improvement…
Added 5 mins ago
Plant Process Engineer
Interplastic Corporation
Hawthorne, CA
The Plant Process Engineer is responsible for optimizing manufacturing processes to improve efficiency, quality, and safety within plant operations. This role works closely with Operations,…
Added 5 mins ago
CMP Process Engineer
Samsung Austin Semiconductor, LLC.
1530 FM 973 Taylor, TX
A CMP (Chemical Mechanical Polishing) Process Engineer is responsible for the critical semiconductor manufacturing step of planarizing the wafer surface. This is achieved through a…
Added 5 mins ago
CMP Equipment Install Engineer
Samsung Austin Semiconductor, LLC.
1530 FM 973 Taylor, TX
An Equipment Installation Engineer operates at the intersection of mechanical engineering, electrical work, and project management. They are responsible for taking a piece of machinery from…
Added 5 mins ago
PI
Powertrain Calibration Lead Engineer
Polaris Industries Inc.
MN
- $80,000 to $105,000 USD / year
The Sr. Powertrain Calibration Lead Engineer owns calibration strategy and delivery for next-generation Polaris powertrains from requirements definition through production release. In this…
Added 6 mins ago
KC
Associate Test Engineer, Analytical Instrumentation
KLA Corporation
Milpitas, CA
- $28.85 to $49.04 USD / hour
…comprised of Manufacturing, Supply Chain Management, Manufacturing Engineering, Installation and Quality, builds our leading-edge technology. GOPS partners with KLA's global supply base and…
Added 6 mins ago
Quality Engineer Senior
Mayville Engineering Co. Brand
Heber Springs, AR
…customer requirements on a continuing basis. Makes suggestions for process…
Added 7 mins ago
Advanced Lead Supplier Quality Engineer - Composites
General Electric Company
Remote, United States
The Supplier Quality Engineer for Polymer Matrix Composites is an individual who can apply knowledge of RCCA and/or problem solving to lead supplier quality improvement of complex cross…
Added 7 mins ago
Principal Hardware Engineer (CRM)
MED Medtronic Inc
Tempe, AZ
The Principal Engineer (ICPE) provides technical leadership and product engineering ownership for custom integrated circuits through the entire product development process until transferred…
Added 7 mins ago
Senior Staff Process Development Engineer
SkyWater Technology Foundry, Inc.
Bloomington, MN
We are seeking a Senior Staff Process Development Engineer to join our team, working on the fabrication and integration of quantum devices in a semiconductor foundry environment.

Nivagen Pharmaceuticals

Sr. Validation Engineer

Sacramento, CA, United States
Pittsburg, CA, United States

$120,000 to $150,000 USD / year

Apply About employer

Applications open in a new tab.

Job details

Pay: $120,000 to $150,000 USD / year
Posting language: English
Posted: Nov 20, 2024

Original job description

About the Company:

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Job Location:

Nivagen Pharmaceuticals Inc., Sacramento, CA

3900 Duckhorn Dr.

Sacramento, CA 95834

About the Job:

Title of the Position: Sr. Validation Engineer

Department: Quality Assurance

Reports to: Director of Validation

Job Summary

The Senior Validation Engineer independently leads validation of processes, equipment, utilities, and systems supporting sterile pharmaceutical production. The role develops scientifically justified validation approaches that meet current Good Manufacturing Practices (cGMP), applicable regulatory requirements, and company procedures. Reporting to the Director of Validation, this position manages projects through the validation lifecycle, resolves complex technical issues, reviews validation deliverables, and mentor's engineers.

Responsibilities

Qualification of Equipment and Systems

Independently plan, author, execute, and technically review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for new and existing equipment and systems.
Lead qualification of sterile manufacturing equipment, facilities, and utilities, including filling lines, isolators, autoclaves, terminal sterilizers, HVAC systems, and critical utilities.
Define qualification scope, test methods, worst-case challenge conditions, and acceptance criteria based on intended use, technical requirements, and quality risk assessments.
Perform and review thermal qualification and environmental mapping studies using Kaye validation systems, temperature and relative humidity data loggers, and calibrated test instruments.

Validation Documentation and Protocols

Author and technically review validation plans, user requirements, risk assessments, protocols, traceability matrices, and final reports, ensuring conclusions are supported by documented evidence.
Verify raw data, calculations, test results, and resolution of discrepancies before recommending completed studies for approval. Maintain accurate, complete, and traceable validation records.
Develop and improve validation procedures and templates; perform periodic reviews and define requalification requirements to maintain the validated state.

Process Validation and Cleaning Validation

Lead assigned process performance qualification activities and support aseptic process simulations in collaboration with Production, Quality Control, Quality Assurance, and technical teams.
Coordinate validation requirements for new products, process transfers, and equipment changes, including study design, sampling plans, and scientifically justified acceptance criteria.
Support the development, execution, and technical review of cleaning validation and verification studies, including worst-case selection, sampling approaches, and evaluation of results against approved limits.

Technical Leadership and Quality Systems

Manage validation projects with Engineering, Operations, Quality, and vendors; establish schedules and resource needs, resolve technical issues, and communicate progress and risks to the Director of Validation.
Lead validation-related deviation investigations, root cause analysis, impact assessments, and corrective and preventive actions (CAPA) through the site quality system.
Assess change controls and performance trends for validation impact; define required qualification, revalidation, or supporting documentation and escalate quality concerns.
Mentor validation engineers, technicians, and contractors; review their protocols and executed documentation for technical accuracy and completeness.
Support audits and regulatory inspections by preparing validation records and explaining study rationale, results, and conclusions.
Perform additional validation-related responsibilities as assigned by the Director of Validation.

Education and Experience

Bachelor's degree or diploma in pharmaceutical sciences, engineering, life sciences, or a related technical field.
Minimum five years of pharmaceutical validation or commissioning and qualification experience, including direct experience in sterile manufacturing.
Strong working knowledge of cGMP, applicable FDA and EMA requirements, relevant ISO standards, validation lifecycle principles, and data integrity expectations.
Demonstrated experience independently leading equipment qualification and process validation projects, including protocol development, execution, technical review, and final reporting.
Experience investigating deviations, assessing change controls, and supporting audits or inspections. Cleaning validation experience is preferred.

Knowledge Skills and Abilities

Excellent technical writing skills and the ability to communicate clear, scientifically justified conclusions.
Strong analytical and troubleshooting skills, with attention to detail when reviewing data and complex technical documentation.
Proficiency in Microsoft Word and Excel and familiarity with electronic systems for collecting, analyzing, and managing validation data.
Strong understanding of aseptic processing, contamination control, and sterile manufacturing practices.

Requirements

Must live or be willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius)
Willing to travel as needed to other manufacturing sites for vendor support

Work Environment

Cleanroom and sterile production areas with controlled environments.
Potential exposure to hazardous materials and chemicals used in pharmaceutical manufacturing processes.

Requirements:

Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius)

Benefits:

Pay range $120,000-$150,000 per Year (based on experience)
Yearly bonus eligibility
Medical, dental and vision coverage
Paid time off plan

Additional Information:

Nivagen is a nicotine-free campus, meaning the use of nicotine products - including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances - is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining Nivagen, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.

Apply About employer

Report this job