Validation Engineer - 20955

Validation Engineer- Simply Biotech     

OVERVIEW     

Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.     

Immediate opening for a Validation Engineer with a biotech company in Torrance, CA who possesses:      
        

• (1–3 years) in validation engineering or a closely related field within a cGMP-regulated pharmaceutical or biotech environment.
• Understanding of process validation, equipment qualification (IQ/OQ/PQ), and pharmaceutical manufacturing processes.
• Bachelor's degree in engineering, Chemistry, or a related scientific discipline/a would be GMP Certification in Compliance/Quality or Validation

Email resumes to kbrace@simplybiotech.com or call 858.683.8559    
        

FULL DESCRIPTION: The Validation Engineer ensures compliance with regulatory and quality standards by managing process and equipment validations. Responsibilities include developing and reviewing URS, performing equipment qualifications (IQ, OQ, PQ), and maintaining essential documentation. This role supports manufacturing compliance, mitigates risks, and prevents delays in production.

The selected candidate will be responsible for:    

• User Requirement Specifications (URS): Develop and refine URS for new and existing process equipment, ensuring alignment with regulatory and manufacturing needs.
• Equipment Qualification (IQ, OQ, PQ): Plan, execute, and document qualification protocols to verify compliance with cGMP requirements.
• Process and Cleaning Validation: Establish validation protocols, identify critical process parameters, and ensure regulatory adherence.
• Validation Documentation: Prepare, review, and archive validation reports, SOPs, protocols, and records to maintain audit readiness.
• Deviation Investigation & CAPA: Diagnose process and equipment issues, implement corrective actions, and address audit observations.
• Scale-Up & Technology Transfer: Support process optimization, seamless scale-up, and method transfer across manufacturing sites.
• Cross-Functional Collaboration: Work with Quality, Manufacturing, and Process Development teams to drive continuous improvement and ensure cGMP compliance.

   
 The selected candidate will also possess:  

• Required: Bachelor's degree in Engineering, Chemistry, or a related scientific field.
• Preferred: Certifications in GMP compliance, quality systems, or validation.
• Experience:
  • 1–3 years in validation engineering or a related field within a cGMP-regulated pharmaceutical or biotech environment.
  • Understanding of process validation, equipment qualification, and pharmaceutical manufacturing processes.
• Knowledge of process validation and equipment qualification within a cGMP framework.
• Proficiency in validation documentation (URS, SOPs, protocols, reports).
• Familiarity with deviation investigations, CAPA processes, and audit responses.
• Basic vendor management skills for coordinating with external equipment/service providers.
• Competence in data analysis tools and MS Office applications.
• Strong problem-solving and analytical abilities.
• Excellent communication and teamwork skills.
• Detail-oriented with a commitment to compliance and accuracy.
• Ability to manage multiple projects under tight deadlines.
• Office-based work with regular coordination of validation activities with some interaction on the production floor.
• Some time spent in cGMP-compliant manufacturing and lab environments requiring PPE.
• Occasional cleanroom work with strict gowning requirements.

 
     
     
   
 Salary Range: $95k-112k/yr  
       
 For immediate and confidential consideration, please email your resume to kbrace@simplybiotech.com or call 858.683.8559. More information can be found at www.simplybiotech.com