Simtra BioPharma Solutions
Cleaning Validation Associate I
Simtra BioPharma Solutions, Bloomington, Indiana, United States, 47401
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 programPerforms carryover (i.e., product, cleaning agent, etc.) limit calculationsWriting 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 studiesCreates and maintains Standard Operating Procedures (SOPs) for cleaning validation programAssembles validation packages and authors validation summaries.
Conducts or coordinates Performance Qualification (PQ) execution for new productsMakes process improvements and modifications to the cleaning validation program, as applicableServe as Subject Matter Expert (SME) for automated/Clean-in-Place (CIP) cleaning systemsPerforms periodic reviews of existing projects, as neededPerforms operator training on new process, as neededServes as liaison between Simtra and the customerParticipates in internal audits and client audits as cleaning validation SMEChange Control Management (CCM) system task ownerCorrective Action Preventative Action (CAPA) system ownerNon-Conformance Report (NCR) investigation ownerRequired qualifications:
BS degree required, preferably in a science or engineering fieldMicrosoft Office (Word, Excel, and Outlook) proficiency - intermediate or higher levelKnowledge of enterprise software systems (i.e., SAP, Maximo, Trackwise, etc.)Ability and experience working independentlyAbility to provide critical thinking and problem-solving skills to day-to-day and project workPhysical / safety requirements:
Duties may require overtime work, nights and weekends and ability to adjust schedule, as neededPosition requires sitting for long hours but may involve walking or standing for periods of timeAble to gown for Grade C requirementsIn return, you'll be eligible for
[1] :
Day One Benefits
Medical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life Insurance
Spouse Life InsuranceChild Life Insurance
Short and Long-Term Disability Insurance401(k) Retirement Savings Plan with Company MatchTime Off Program
Paid HolidaysPaid Time OffPaid Parental Leave and more
Adoption Reimbursement ProgramEducation Assistance ProgramEmployee Assistance ProgramCommunity and Volunteer Service Program
Additional Benefits
Voluntary Insurance Benefits
Vision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and more
Onsite Campus Amenities
Workout FacilityCafeteriaCredit Union
[1] Current benefit offerings are in effect through 12/31/24
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 LawEEO is the law - Poster SupplementPay 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
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 programPerforms carryover (i.e., product, cleaning agent, etc.) limit calculationsWriting 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 studiesCreates and maintains Standard Operating Procedures (SOPs) for cleaning validation programAssembles validation packages and authors validation summaries.
Conducts or coordinates Performance Qualification (PQ) execution for new productsMakes process improvements and modifications to the cleaning validation program, as applicableServe as Subject Matter Expert (SME) for automated/Clean-in-Place (CIP) cleaning systemsPerforms periodic reviews of existing projects, as neededPerforms operator training on new process, as neededServes as liaison between Simtra and the customerParticipates in internal audits and client audits as cleaning validation SMEChange Control Management (CCM) system task ownerCorrective Action Preventative Action (CAPA) system ownerNon-Conformance Report (NCR) investigation ownerRequired qualifications:
BS degree required, preferably in a science or engineering fieldMicrosoft Office (Word, Excel, and Outlook) proficiency - intermediate or higher levelKnowledge of enterprise software systems (i.e., SAP, Maximo, Trackwise, etc.)Ability and experience working independentlyAbility to provide critical thinking and problem-solving skills to day-to-day and project workPhysical / safety requirements:
Duties may require overtime work, nights and weekends and ability to adjust schedule, as neededPosition requires sitting for long hours but may involve walking or standing for periods of timeAble to gown for Grade C requirementsIn return, you'll be eligible for
[1] :
Day One Benefits
Medical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life Insurance
Spouse Life InsuranceChild Life Insurance
Short and Long-Term Disability Insurance401(k) Retirement Savings Plan with Company MatchTime Off Program
Paid HolidaysPaid Time OffPaid Parental Leave and more
Adoption Reimbursement ProgramEducation Assistance ProgramEmployee Assistance ProgramCommunity and Volunteer Service Program
Additional Benefits
Voluntary Insurance Benefits
Vision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and more
Onsite Campus Amenities
Workout FacilityCafeteriaCredit Union
[1] Current benefit offerings are in effect through 12/31/24
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 LawEEO is the law - Poster SupplementPay 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