Sterility Assurance Validation Associate ; 1st shift

Sterility Assurance Validation Associate I (1st shift)

Bloomington, Indiana, United States

Simtra Bio Pharma Solutions (Simtra) is a world‑class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring sterile injectable products to market. With facilities in Bloomington and Halle/Westfalen, we offer a wide range of delivery systems including pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials and sterile crystallization.

Professional focus is cGMP manufacturing, with support services such as formulation and development, lyophilization optimization, global regulatory support and secondary packaging. The emphasis is on quality and continuous improvement, ensuring the highest regulatory standards.

This role: The Sterility Assurance Validation Associate I is responsible for managing and executing project and system qualifications, validating confirmations of equipment and processes, and ensuring compliance with worldwide regulatory agency requirements and internal best practices. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Services Validation Manager.

Responsibilities:

• Document new protocols, SOPs, and summary reports for processes, updating existing documents as required.
• Conduct development studies on critical equipment.
• Own and onboard new client projects, including syringe‑line validations.
• Serve as line owner, performing gap assessments and defining validation approaches for new projects.
• Collaborate directly with client representatives.
• Own and investigate non‑conformance reports (NCR) and manage corrective and preventive actions (CAPA).
• Manage change control tasks (CCM).
• Participate in client audits, provide rationale and justification for practices, and respond to audit observations and deliverables.
• Act as subject‑matter expert for up to three processes, technologies, or equipment.
• Plan and lead syringe‑line media fills and maintain full ownership through closure.
• Drive value‑improvement projects to realize savings.
• Perform semi‑annual HEPA filter certification testing (integrity, velocity, and visible smoke testing).

Required qualifications:

• BS degree in a science related field with laboratory experience or high‑school diploma/GED with a minimum of six years in the pharmaceutical, biotechnology, or related industry with comparable responsibilities (e.g., technical writing, audit experience, project lead).
• Proficiency with enterprise software (JDE, BPLM, Pilgrim, Trackwise, Ellab Valsuite Pro, etc.).
• Critical‑thinking and problem‑solving skills.
• Initiative and ability to handle ambiguity.
• Professional and collaborative communication with client representatives.
• Strong technical writing and oral communication skills.

Physical / safety requirements:

• Meet Grade A and B gowning requirements.
• Lift up to 50 lbs.
• Climb and work from ladders.
• Ability to work overtime, including nights and weekends.
• Stand for long periods; walking or sitting may also be required.

Simtra is a proud equal‑opportunity employer and evaluates applicants solely on qualifications and abilities, without regard to race, color, religion, gender, nationality, age, sexual orientation, gender identity, protected veteran status, disability or other legally protected characteristic.

All job descriptions are subject to the minimum knowledge, skills and abilities necessary to perform the job and may be modified based on business needs.