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Active4w ago

Validation Engineer - Pharmaceutical Sterile Manufacturing

Nivagen Pharmaceuticals·📍 Sacramento, CA 95834

Employment

Full-Time

Work mode

On-site

Experience

MID LEVEL

Salary

Not disclosed

Salary not disclosed

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Role overview

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 fosterin

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What they are looking for

Skills & requirements

Qualification

Education/Experience: Bachelor's degree or Diploma in Pharmaceuticals, or a related field. Minimum 2 years of experience in a pharmaceutical manufacturing or validation role, with a focus on sterile manufacturing (e.g., aseptic processing, sterile filling, isolator, autoclave sterilization). Strong understanding of cGMP, FDA, EMA, ISO standards, and other relevant regulatory requirements. Experience with equipment validation (e.g., filling machines, autoclaves, and HVAC systems) and process validation. Familiarity with the documentation requirements for validation, including protocol development, execution, and report writing Knowledge, Skills, and Abilities: Excellent technical writing and documentation skills. Strong attention to detail and ability to manage complex technical documentation. Ability to work cross-functionally and manage multiple priorities. Familiarity with data analysis tools and software used for validation testing and reporting (e.g., Excel, Validation Master Plans, LIMS systems). Aseptic processing or sterile manufacturing practices. Requirements: Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius) Willing to travel as nee

Department · Engineering & Maintenance

Nivagen Pharmaceuticals logo

Hiring company

Nivagen Pharmaceuticals

Healthcare

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