Validation Lead/Associate III, Commissioning Qualification, Validation

Simtra BioPharma Solutions•Bloomington, IN

About The Position

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Why join Team Simtra? Because we: Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health. This role: The Validation Associate III is a strong individual contributor within the Validation and Qualification Department. This position oversees and executes equipment FAT, SAT, IQ, OQ, PQ activities along with validation and documentation activities. In addition, it includes contribution roles within Sterility Assurance and Cleaning Validation. This position reports to the Sr. Manager, Technical Services.

Requirements

Bachelor’s degree required, preferably in a science or technical area
Minimum of 2 years related experience required, preferably 2 years supervisory experience.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
Self-directed with high initiative and ownership
Critical thinking, creative thinking, and problem solving skills
Ability to meet Grade C and D gowning requirements.
Duties will require overtime work, including nights and weekends.
Use of hands and fingers to manipulate equipment is required.
Position requires standing for long hours, but may involve walking or sitting for periods of time.

Responsibilities

Provide guidance, support, direction, and leadership through positive interaction with all personnel during daily operations.
Represents CQV in internal, client, and regulatory audits as needed.
Develops procedures and supports the facility equipment qualification and validation program.
Conducts or coordinates performance qualification execution for new products.
Maintain and generate accurate and complete records, reports and documentation as required for summary preparation.
Makes process improvements and modifications to the validation program as needed.
Initiates and drives change controls (CCM).
Review and approve Master Batch Records, Master Specification Sheets, Line Manufacturing Records and Bill of Materials.
Author and approve qualification and validation documents
Attend Equipment FAT, including international travel as required.
Leads and participates in planned maintenance activities, including HEPA certification and visual airflow testing (smoke testing).