Computer Systems Validation Associate II
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
For over 65 years pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.
Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana US and Halle/Westfalen Germany. We offer a wide-range of delivery systems including prefilled-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 at Simtra there is a strong emphasis on quality and continuous improvement. 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.
In addition to unmatched expertise and experience we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.
It is very rewarding industry to work in. Our teams are driven to help clients scale innovate and bring-life changing medicines to patients worldwide.
The Validation Associate II is a key member of the Computer Systems Validation team within the Technical Services organization. The Validation Associate II must have a working knowledge of the overall requirements dictated by worldwide regulatory agencies with respect to computer systems validation. This position works directly with the Information Technology department and other functional areas and is considered the lead validation resource. The Validation Associate II understands industry best practices and maintains a state of audit readiness always. This position reports to the Manager Computer Systems Validation.
What youll be doing:
- Validation document author/reviewer VP URS FS/DS TM IQ OQ PQ using established templates
- Technical writing proficiency VP URS FS/DS TM IQ OQ PQ using established templates.
- Entitlement Reviews Coordinates user access reviews for recertification and authorization
- Local Change Control owner
- CSV periodic reviews to maintain the validated state the Associate willperform periodic reviews of validation packages per established procedures
- Validation lead GAMP Category 1 - 4
- Client audits The Associate will participate in client audits responding verbally to auditors questions.
- Global Change Control task owner
- System assessments Quality Regulatory Risk Gap CAPA owner
- NCR/SNCR investigator
- Validation Lead for implementation of major and minor software applications or modules for Good Manufacturing Practices (GMP) use
- Completes detailed risk assessment and 21 CFR part 11 Gap analysis
- Maintains departmental compliance with regulations and corporate procedures
- Coordinates computer systems implementation activities with Vendors and other non-BPS resources
- Creates/Reviews validation documentation templates procedures and all documentation generated during a computer systems validation project
- Participates in Internal/Client/Corporate Audits
- Represents validation department as validation expert in cross-functional work teams
- Advocates and understands best practices for system validations and processes
- Articulates complex systems and communicates to technical and nontechnical management
What youll bring:
- BS in Electronic or Software Engineering Information Systems or a related field
- 3 years experience of working within a regulated environment (worldwide regulatory agencies) particularly in computer systems validation or other validation discipline
- Ability to use enterprise software (i.e. ERP EDMS QMS JDE Trackwise etc.)
- Experience with Microsoft Project
- Technical writing skills
Physical / Safety Requirements
- Duties may require overtime work including nights and weekends
- Use of hands and fingers to manipulate office equipment is required
- Position requires sitting for long hours but may involve walking or standing for periods of time
#IND-USOPS #LI-TL1
Equal Employment Opportunity
Simtra is 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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Experience:
IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
THIS IS WHERE IT ALL BEGAN Did you know that Baxter is the first commercial manufacturer of prepared IV solutions? It all started in 1931 in Iowa when Dr. Ralph Falk and Dr. Donald Baxter launched the Don Baxter Intravenous Products Company. Hillrom’s roots go back to when Bill Hille ... View more
