ARGOS IS GROWING!
After having met several important milestones including exciting clinical data, we are poised for new strategic objectives which will require significant new resources. Those new resources include a well-qualified Senior Computer Validation Engineer.
Prepare, execute, and summarize validation protocols and other validation related documents (risk assessments, validation plans, trace matrix, periodic reviews, etc.) to support new or existing computerized system, including spreadsheets, used for or in support of GMP activities.
- Write, execute, summarize and review validation protocols and pre-validation testing (FAT, SAT, UAT, etc.).
- Lead the resolution of deviations noted during protocol execution.
- Analyze and summarize Periodic Reviews of previously validated systems, and develop/implement protocols/changes based on outcome of the review.
- Assist user groups in troubleshooting and analyzing systems for research, process development, and cGMP processes and testing. Participation may include selection process for new systems to help improve work practices or product quality using previously obtained validation data.
- Lead the development and maintain risk assessments, URS/FR/DS, validation plans, and trace matrices.
- Follow departmental and company-wide SOPs and policies.
- Revise procedures based on established industry best practices and regulations/ guidance documents.
- Review or author new validation, commissioning, and risk assessment procedures based on established industry best practices and regulations/guidance documents.
- Assess new regulations and guidance documents in the use of systems in a GMP environment and develop/revise programs to ensure continued compliance.
- As needed, manage and serve as the information resource for contractors and vendors hired to support validation activities.
- Other duties as required.
- 7+ years of validation experience in a biotech/pharmaceutical environment, specializing in Computer System Validation with strong experiences in other validation areas which may include Equipment/Facility/Utility qualification, Lab Equipment/System qualification, or Process Validation.
- Bachelor’s degree, preferably in a technical/science/mathematical field.
- Working knowledge in the application and implementation of 21 CFR Part 11 and EudraLex 4.
- Direct validation experience related to enterprise systems including EDMS, BMS/BAS, LIMs, and MES, as well as spreadsheet validation.
- Strong written and oral communication skills with ability to interact with various individuals and roles throughout the organization and with external consultants.
- Results oriented, self-motivated, self-starter with flexibility to adapt to changing priorities and ability to manage multiple projects/activities simultaneously.
- Strong working knowledge of good documentation practices and FDA/EU regulatory requirements and guidance documents.
- Good interpersonal, organizational and trouble shooting skills.
- Strong ability and willingness to learn and work within a team environment.
- Ability to lift up to 20 pounds and willingness to be regularly, predictably and reliably at work.
- Direct experience working in cleanrooms or sterile facilities is preferred, but not required.
- 2+ years of managing/leading validation direct reports or contractors/consultants is preferred, but not required.
- Ability and willingness to be regularly, predictably and reliably at work.
We offer a competitive compensation package along with outstanding benefits. For confidential consideration, please submit a resume with a cover letter and salary history.
No phone calls please.
Argos Therapeutics is an Equal Opportunity Employer.