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
  • Develops, validates and onboards cleaning processes for new products
  • Perform cleaning risk assessments to determine acceptance criteria for residue limits
  • Manages the CV team to deliver non-conformance reports (NCRs), corrective action-preventive action (CAPAs) documentation, and change control management (CCM) on-time
  • Proactively and routinely provides status of key projects to management
  • Establishes a culture of accountability; holds employees and their performance to account and disciplines accordingly
  • Participates in regulatory inspections, internal audits, and client audits as cleaning validation subject matter expert (SME) and develops team to be SMEs for audits
  • Reviews and approves validation documents
  • Conducts performance evaluations
  • Drive improvements in the CV program

• Strategy:
  • Strategically sets goals for CV function to support site goals and metrics
  • Sets direction for the CV program to satisfy existing and future business, client and regulatory demands
  • Develops, coaches, mentors, and trains CV employees on necessary skills, including technical writing skills and client interfacing support skills
  • Facilitates career progression of direct reports

• General:
• Performs supervisory duties for team - using Dayforce, managing PTO, CAPA management, etc.

Required qualifications:

• BS degree, preferably in science or engineering discipline
• 5+ years experience in pharmaceutical/cGMP environment
• 2+ years of supervisory/leadership experience
• Excellent technical writing skills
• Advanced proficiency in MS Office Suite (Word, Excel, Outlook)
• Demonstrated ability to use enterprise software (Veeva, Trackwise, etc.)

Physical / safety requirements:

• Duties will require overtime work, including nights and weekends on occasion
• Position requires sitting for long hours and may involve walking or standing for periods of time
• Must be able to gown for Grade C area

In return, you’ll be eligible for [1]:

• 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 and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[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.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy