Process Validation Associate III

Simtra BioPharma Solutions • Bloomington, IN

122d

About The Position

This position executes process validation activities that meet worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position interacts with the client and the cross functional client team members to develop process validation strategies and creates process validation protocol and summary documents. This position reports to the Sr. Manager, Technical Services, and is 100% onsite at the Bloomington, Indiana facility.

Requirements

• BS degree, preferably in a science or engineering related field
• 2+ years pharmaceutical industry experience in parenteral manufacturing
• Experience working independently or in a team
• Knowledge of pharmaceutical manufacturing industry
• Experience executing projects
• Experience identifying opportunities for optimization of processes/projects
• Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
• Experience using enterprise software (i.e., JDE, Veeva, Trackwise, etc.)

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
• Uses statistical tools to analyze process validation data
• Performs annual reviews / continued process verification (CPV) of validation projects
• Investigates and executes 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, as needed
• Participates in regulatory, client and internal audits

Benefits

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• 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 Insurance
• Critical Illness Insurance
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal Insurance
• Onsite Campus Amenities
• Workout Facility
• Cafeteria
• Credit Union

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees