Sr. Sterility Assurance Validation Technician (1st shift)

Job Description

Simtra BioPharma Solutions is seeking a Senior Validation Technician to join its Sterility Assurance Team in Bloomington, Indiana. This role involves performing validation studies on pharmaceutical equipment and processes to ensure successful operation and maintain qualified equipment. The Senior Validation Technician will support routine and non-routine validations, confirmations, and assist other technicians and validation associates.Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market.Responsibilities:

• Performs validation studies on pharmaceutical equipment and processes.
• Leads and documents validations/qualifications on pharmaceutical equipment.
• Uses equipment/instruments and computer systems to collect critical data.
• Works with biological indicators and endotoxin indicators.
• Follows written procedures during validation studies.
• Maintains and generates accurate records and documentation.
• Performs calibrations of data logging equipment and sensors.
• Participates in HEPA filter certification testing.
• Revises procedures and forms to improve Sterility Assurance Validation processes.
• Assists with routing validation documentation for approvals.

Requirements:

• High School diploma or equivalent.
• 0-2 years relevant experience in validation, technical services, or pharmaceutical manufacturing.
• Intermediate proficiency in Microsoft Office Suite.
• Ability to use enterprise software (Trackwise, JDE, Ellab).
• Attention to detail and strong communication skills.
• Ability to work with cross-functional teams.
• Ability to lift 50 lbs, climb ladders, and meet Grade A and B gowning requirements.

Simtra BioPharma Solutions offers:

• Day One Benefits including 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.
• Time Off Program, Paid Holidays, and Paid Parental Leave.
• Adoption Reimbursement Program and Education Assistance Program.
• Employee Assistance Program and Community and Volunteer Service Program.
• Voluntary Insurance Benefits including Vision Coverage, Accident, Critical Illness, and Identity Theft Protection.
• Onsite Campus Amenities including a Workout Facility and Cafeteria.