Sterile Pharmaceutical Validation Engineer

Nivagen Pharmaceuticals; Sacramento (CA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k savings plan

Yearly bonus eligibility

Job summary

A pharmaceutical company in Sacramento is seeking a Validation Engineer to ensure that manufacturing processes and equipment meet all regulatory requirements. Responsibilities include performing equipment qualification, preparing validation documentation, and managing process validations. Ideal candidates will have a Bachelor's degree in Pharmaceuticals, at least 2 years of experience, and a strong understanding of cGMP and FDA standards. This role offers competitive benefits and a yearly bonus.

Qualifications

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

Responsibilities

• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Prepare and review validation reports for compliance.
• Conduct process validation studies for pharmaceutical products.

Skills

Technical writing

Attention to detail

Data analysis

Education

Bachelor's degree or Diploma in Pharmaceuticals

Tools

Kaye validator

LIMS systems

Excel

Job description

A pharmaceutical company in Sacramento is seeking a Validation Engineer to ensure that manufacturing processes and equipment meet all regulatory requirements. Responsibilities include performing equipment qualification, preparing validation documentation, and managing process validations. Ideal candidates will have a Bachelor's degree in Pharmaceuticals, at least 2 years of experience, and a strong understanding of cGMP and FDA standards. This role offers competitive benefits and a yearly bonus.