Browse All Jobs

Process Validation Associate I

Process Validation Associate I role at Simtra BioPharma.
Simtra BioPharma Solutions
On-Site
United States
Undisclosed salary
Job Description
Simtra BioPharma Solutions is seeking a Process Validation Associate I to join their team in Bloomington, Indiana. This role is crucial for executing process validation activities that align with global regulatory standards and internal best practices. The Process Validation Associate I will collaborate with clients and cross-functional teams to develop effective process validation strategies and documentation.

Responsibilities:
  • Supports the process validation program
  • Interacts with the client and client team to define process validation scope
  • Designs and executes the appropriate development Technical Studies to define process parameters
  • Creates a risk assessment of the process to be validated
  • Creates process validation protocols
  • Conducts and coordinates process performance qualification (PPQ batch) execution for new and existing products
  • Prepares validation summaries
  • Performs annual reviews / continued process verification (CPV) of validation projects
  • Investigates and executes validation related Corrective and Preventive Actions (CAPA) Non-conformance Report (NCR) investigation owner for process validation related, as needed

Requirements:
  • BS degree, preferably in a science or engineering-related field
  • Experience in a laboratory (academic or industry) environment
  • Knowledge of pharmaceutical manufacturing industry
  • Intermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
  • Knowledge of enterprise software (i.e., JDE, Veeva, Trackwise, LIMS, Electronic Laboratory Notebooks, etc.)

Simtra BioPharma Solutions offers:
  • Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Paid Time Off
  • Paid Holidays
  • Paid Parental Leave
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Onsite Campus Amenities including a Workout Facility, Cafeteria, and Credit Union
Apply Manually

Simtra BioPharma Solutions

All Jobs at Simtra BioPharma Solutions (118)