Validation Engineer II

Kindeva Drug Delivery

$75K — $95K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Chemistry, Biochemistry, Microbiology, Pharmacy or related discipline
  • 5+ years of relevant validation or pharmaceutical manufacturing experience, or equivalent combination of education and experience
  • Knowledge of cGMP and regulatory guidance
  • Experience in aseptic manufacturing and inspection/packaging operations
  • Ability to interpret technical documentation and identify deviations
  • Proficiency with Microsoft Office applications
  • Flexibility to adapt to multiple GMP environments with regular site travel

Responsibilities

  • Provide validation support across multiple sites based on business priorities
  • Assist in equipment qualification (IQ/OQ/PQ), cleaning validation, process validation, and CSV
  • Execute and author validation protocols and reports
  • Support aseptic manufacturing and inspection/packaging validation activities
  • Issue validation data, protocols, reports, and technical memos
  • Support site change management programs and maintain validated states
  • Assist with Validation Master Plans and Continuous Process Verification activities
  • Review vendor turnover packages and User Requirement Specifications

Benefits

  • Flexible cross-site validation coverage
  • Opportunities to work across diverse pharmaceutical environments
  • Involvement in continuous process verification and validation master plans
  • Exposure to various stages of manufacturing and quality assurance
  • Collaboration with a range of technical personnel in the industry
Full Job Description
The Impact You Will Make

The Floater Validation Engineer II provides validation engineering support across two pharmaceutical aseptic manufacturing facilities and one inspection and packaging site. This role assists with equipment qualification, aseptic process validation, cleaning validation, computer systems validation, and inspection/packaging validation activities. The position delivers flexible, cross-site validation coverage while executing protocols, performing testing, and authoring validation documentation under the direction of the Validation Manager.

Responsibilities
• Provide validation support across multiple sites based on business priorities.
• Assist in equipment qualification (IQ/OQ/PQ), cleaning validation, process validation, and CSV.
• Execute and author validation protocols and reports.
• Support aseptic manufacturing and inspection/packaging validation activities.
• Issue validation data, protocols, reports, and technical memos.
• Support site change management programs and maintain validated states.
• Assist with Validation Master Plans and Continuous Process Verification activities.
• Review vendor turnover packages and User Requirement Specifications.

Qualifications
  • Bachelor's degree in Engineering, Chemistry, Biochemistry, Microbiology, Pharmacy or related discipline
  • 5+ years of relevant validation or pharmaceutical manufacturing experience, or equivalent combination of education and experience.
  • Knowledge of cGMP and regulatory guidance.
  • Experience in aseptic manufacturing and inspection/packaging operations.
  • Ability to interpret technical documentation and identify deviations.

• Proficiency with Microsoft Office applications.
  • Regular travel between sites required; ability to adapt to multiple GMP environments.

#LI-ON-SITE

California residents should review our Notice for California Employees and Applicants before applying.

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees-regardless of format-without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

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