Process Validation Associate III

Simtra BioPharma Solutions is seeking a Process Validation Associate III to execute process validation activities, interact with clients and cross-functional teams, and create validation protocols. This role is fully onsite at the Bloomington, Indiana facility and is crucial for supporting cGMP manufacturing and ensuring product quality.

Requirements

• 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
• Conducts and coordinates process performance qualification (PPQ) execution for new and existing products
• Prepares validation summaries
• Performs annual reviews / continued process verification (CPV) of validation projects
• Prepares validation related Corrective and Preventive Actions (CAPA)
• Demonstrate ability to communicate effectively at all levels
• Non-conformance Report (NCR) investigation owner for process validation related
• Participates in regulatory, client and internal audits

Benefits

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Child Life Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Voluntary Insurance Benefits
• Vision Coverage
• Accident
• Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal and more
• Onsite Campus Amenities
• Workout Facility
• Cafeteria
• Credit Union