Cleaning Validation Associate I - Simtra BioPharma Solutions : Job Details

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:This position executes cleaning validation activities that meet global regulatory agency requirements, internal company standards/best practices and current industry practices. This position interacts with manufacturing to develop and validate cleaning procedures, trains operators on the validated processes, and creates the Good Manufacturing Practices (GMP) documentation for validated projects to support the cleaning validation program. This position is 100% onsite at the Bloomington facility and reports to the Sr. Manager, Cleaning Validation.The responsibilities:

• Supports the facility equipment cleaning validation program
• Performs carryover (i.e., product, cleaning agent, etc.) limit calculations
• Writing and maintaining technical documentation:
  • Designs and executes Cleaning Validation (CV) protocols and Technical Services Studies (TSS)
  • Creates CV summaries based on data analysis from executed studies
  • Creates and maintains Standard Operating Procedures (SOPs) for cleaning validation program
  • Assembles validation packages and authors validation summaries.
• Conducts or coordinates Performance Qualification (PQ) execution for new products
• Makes process improvements and modifications to the cleaning validation program, as applicable
• Serve as Subject Matter Expert (SME) for automated/Clean-in-Place (CIP) cleaning systems
• Performs periodic reviews of existing projects, as needed
• Performs operator training on new process, as needed
• Serves as liaison between Simtra and the customer
• Participates in internal audits and client audits as cleaning validation SME
• Change Control Management (CCM) system task owner
• Corrective Action Preventative Action (CAPA) system owner
• Non-Conformance Report (NCR) investigation owner

Required qualifications:

• BS degree required, preferably in a science or engineering field
• Microsoft Office (Word, Excel, and Outlook) proficiency - intermediate or higher level
• Knowledge of enterprise software systems (i.e., SAP, Maximo, Trackwise, etc.)
• Ability and experience working independently
• Ability to provide critical thinking and problem-solving skills to day-to-day and project work

Physical / safety requirements:

• Duties may require overtime work, nights and weekends and ability to adjust schedule, as needed
• Position requires sitting for long hours but may involve walking or standing for periods of time
• Able to gown for Grade C requirements

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
• 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 12/31/24DisclaimerThis 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 OpportunitySimtra 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 PolicyData PrivacyTo learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: