Computer Systems Validation Associate II

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 you'll 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 will perform 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 auditor’s 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 you'll 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

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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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