Sterile Validation Engineer — GMP/FDA Compliance Champion

Nivagen Pharmaceuticals, Inc.; Sacramento (CA); On-site; USD 90,000 - 105,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

401k savings plan

Yearly bonus eligibility

Job summary

A pharmaceutical company in Sacramento is seeking a Validation Engineer responsible for ensuring compliance with regulatory requirements and industry standards in sterile manufacturing processes. You will lead the validation lifecycle from installation through qualification, conduct process validation studies, and prepare necessary documentation. Candidates should possess a Bachelor's degree and a minimum of 2 years of experience in a related role. The position offers a salary range of $90,000 to $105,000 plus benefits.

Qualifications

• Minimum 2 years of experience in pharmaceutical manufacturing or validation role.
• Strong understanding of cGMP, FDA, EMA, ISO standards.
• Experience with equipment and process validation.

Responsibilities

• Perform installation, operational, and performance qualifications of equipment.
• Prepare and review validation documentation and protocols.
• Conduct and manage process validation studies.

Skills

Technical writing

Attention to detail

Cross-functional collaboration

Data analysis tools

Aseptic processing

Education

Bachelor's degree in Pharmaceuticals or related field

Tools

Excel

LIMS systems

Job description

A pharmaceutical company in Sacramento is seeking a Validation Engineer responsible for ensuring compliance with regulatory requirements and industry standards in sterile manufacturing processes. You will lead the validation lifecycle from installation through qualification, conduct process validation studies, and prepare necessary documentation. Candidates should possess a Bachelor's degree and a minimum of 2 years of experience in a related role. The position offers a salary range of $90,000 to $105,000 plus benefits.