Process Validation Engineer

job summary:
Join Our Client as a Process Validation Engineer in Carlsbad, CA a top 3 R&D investor in Life Sciences! We need an SME with a BS/MS, 7+ yrs cGMP exp, 5+ yrs process validation (PPQ/CPV), and FDA BLA filing experience to lead validation strategies.

location: Carlsbad, California
job type: Contract
salary: $57 - 72 per hour
work hours: 8am to 5pm
education: Bachelors

responsibilities:

• Lead process validation (PPQ/CPV), risk assessments, and process hold time, mixing, and homogeneity studies for commercial drug substance manufacturing.

• Establish API manufacturing process control strategies, evaluate process performance, and generate robust CPV and process validation documentation.

• Partner closely with Manufacturing, Process Development, QC, QA, and Project Management to ensure CMC and scientific strategies remain robust and aligned.

• Lead process validation investigations, execute complex impact assessments with clear rationale, and represent MSAT as the SME in customer meetings and regulatory audits.

• Support BLA filings with the FDA and regulatory agencies while managing workload independently in a fast-paced cGMP environment.

qualifications:

• Experience level: Experienced
• Education: Bachelors

 
skills:

• Process Validation
• GMP
  
  
  
  
  Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
  At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on us.fitly.work.
  
  
  
  
  Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
  
  
  
  
  This posting is open for thirty (30) days.
  Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
  
  
  
  
  Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
  
  
  
  
  We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.