What are the responsibilities and job description for the Cleaning Validation Manager position at Baxter Pharmaceutical Solutions LLC.?
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 Cleaning Validation (VC) Manager position is responsible for leading and managing the cleaning validation team and program in compliance with current Good Manufacturing Practices (cGMP) regulations and industry standards. This role ensures that the manufacturing equipment and facilities are effectively cleaned to prevent cross-contamination, ensuring product quality and patient safety. This position reports to the Technical Services Director and is 100% onsite at the Bloomington facility.
The responsibilities :
- Department performance :
Manages the CV team and program to maintain the validated status of existing product cleaning processes, to consistently deliver projects on time, and to consistently maintain training compliance
Strategically sets goals for CV function to support site goals and metrics
Required qualifications :
Physical / safety requirements :
In return, you'll be eligible for [1] :
Medical & Dental Coverage
Spouse Life Insurance
Paid Holidays
Voluntary Insurance Benefits
Vision Coverage
Workout Facility
1] Current benefit offerings are in effect through 12 / 31 / 25
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability / handicap status or any other legally protected characteristic.
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