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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Computer Systems Validation, including the development of GxP documentation and compliance with 21 CFR Part 11. Proven ability to lead teams, foster a customer-focused environment, and drive initiatives that align with organizational strategy.
Highest-signal resume keywords
Computer Systems ValidationGxP Documentation21 CFR Part 11 ComplianceGMP Environment ExperienceAseptic Process Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Computer Systems ValidationGxP Documentation21 CFR Part 11Data IntegrityFilling Line CSVAutomation ExperienceGAMP ComplianceConsent Decree ExperienceMESDelta V
Soft Skills
Excellent Communication SkillsCoaching and DevelopmentNegotiation SkillsCustomer FocusLeadership
Tools & Technologies
Industrial SystemsPIGMP Systems
Industry Keywords
BiotechPharmaAseptic ProcessGMPCompliance
About the role
Key responsibilities & impact- Develop and execute computer systems validation protocols and test scripts
- Identify gaps and consult on and direct plans for resolution
- Write GxP computer validation and 21 CFR Part 11 documentation, including assessments, plans, URS, FRS, RTM, and summary reports
- Create strategies balancing short-term requirements with long-range business plans
- Pursue initiatives to capitalize on strengths and market opportunities
- Align area priorities with broader organizational strategy
- Apply commercial, financial, and economic insights to improve results
- Promote risk awareness and review risk-management performance
- Foster a customer-focused environment and anticipate customer requirements
- Maintain accountability, delegate assignments, monitor progress, and redirect efforts
- Ensure people have the resources, information, authority, empowerment, and support needed to achieve objectives
- Negotiate persuasively and cultivate organizational networks
- Inspire, coach, and develop others
- Provide feedback and guidance to enhance skill development
- Develop successors and talent pools
- Promote recruitment and advancement of diverse talent
- Foster energy, ownership, commitment, challenging goals, and performance excellence
- Develop and drive a safe and inclusive work culture
- Lead with integrity, challenge established practices, and develop breakthrough ideas and safe working processes
- Travel throughout Italy and abroad
Requirements
What you’ll need- BS in Computer Science or Engineering, or equivalent experience
- 2–7 years’ experience with Computer Systems Validation
- 2 years’ experience working in a GMP environment
- Aseptic process knowledge
- Filling line CSV and automation experience
- Experience in data integrity with GAMP and 483 compliance
- Consent decree experience
- Deep 21 CFR Part 11 experience is highly desired
- Experience in biotech and pharma preferred over medical device
- Experience with MES, Delta V, PI, or other major industrial systems and platforms
- Excellent oral and written communication skills in English / fluent in English
- Able to travel domestically and internationally as required
- European citizenship or a valid residence permit for Europe required
Benefits
Comp & perks- Gross annual salary of €34,000–€45,000
- Travel opportunities domestically and internationally