Principal Computer Software Validation Engineer (Csv), Quality

Overview

The Principal Engineer of Computer Systems Validation will oversee the GxP computerized systems validation and provide QA oversight. The individual ensures that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and company procedures. This position is hands on role and the individual may have an opportunity to build a team with Computer Software Validation (CSV) and Computer Software Assurance (CSA) programs. This is a highly visible role with multi-sites responsibility and cross-functional leadership. Individual will report to the Head of Quality Assurance.

Please note: This job can be worked from either our St. Paul, MN or Atlanta, GA facility.

Responsibilities

• Develop and implement CSV and Data integrity processes to ensure compliance with GxP, GAMP, OECD and applicable regulations in conjunction with operations counterpart.

• QA and compliance expertise and management of all validation activities including

• Leading role in all CSV validation projects

• Ensuring compliance to internal SOPs and regulatory requirements

• Assisting with issues, bugs and deviations adequate processing and documentation.

• Reviewing/approving the validation deliverables

• Ensure the organization is always ready for third party and government Inspections

• Provide training on validation related topics.

• Subject Matter Expert for Computerized System Related SOPs, regulations and industry best-practices. Participate as needed to support Client and Regulatory audits.

• Works cross functionally with Operations, IT, and QA Staff.

• Write, execute, review, or approve Software Validation documentation, in addition to guiding peers in the writing and execution of Equipment and Software Validations.

• Collaborate with testing and manufacturing personnel, system vendors, IT and QA to support new systems introduction for GXP use (including supports with developing URS and FDS).

• Write, execute, review, or approve Change Controls; assess impact to qualified state of systems for proposed changes; develop appropriate mitigation plan, as applicable.

• Participates in generating impact assessments, risk assessments, requirements traceability, URS, FDS, procedural mappings and Validation Project Plans in server or clouds systems.

• Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (i.e.: ICH, ISPE, GAMP, ISO, etc.).

• Oversee and manage CSV Staff, if applicable.

• Interact frequently with laboratory/manufacturing/facility staff to provide expertise on equipment/software validations. Address conditions/practices with appropriate personnel, reports findings to QA and Operations Management.

• Participate in quality and process improvement initiatives, and project teams.

• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.

• Contributes to the overall operations and to the achievement of departmental goals.

• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.

• Other duties as assigned

Qualifications

Experience / Education

• 10 + years of relevant experience or equivalent in managing and/or supporting Computer System/Software Validation in GxP biotechnology, laboratory testing and/or manufacturing industries.

• Bachelors' degree in a Science, Engineering or related field or equivalent experience

• Advanced degree preferred

Knowledge / Skills / Abilities:

• Knowledge of 21 CFR Part 11, GAMP, CSV and CSA.

• Knowledge of cGMP/GLP requirements, and ISO 17025 is highly desirable.

• Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, Outlook, Access, and Monday.com).

• Need to be able to read, write and understand English

Physical Requirements:

• Must be able to work in an office environment with minimal noise conditions.

• Must be able to work in Lab setting with Biohazards /various Chemicals

• Must be able to wear appropriate PPE

• Ability to stand /sit/walk for long periods of time

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.