Validation Engineer I

🕒 vor 15 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $20 - $23 / Stunde

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

👷🏻‍♀️ Ingenieur

🦅 H1B-Visum-Sponsor

infoinfo

👻 Geisterscore 1%

infoinfo

🗣️🇺🇸🇬🇧 Englisch erforderlich

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Logo of PSC Biotech Corporation

PSC Biotech Corporation

201 - 500 Mitarbeiter

Gegründet 1996

💼 Beratung

🏥 Gesundheitswesen

🧬 Biotechnologie

Consulting • Healthcare • Biotechnology

Die PSC Biotech Corporation ist ein Lösungsanbieter im Bereich der Lebenswissenschaften, der ein breites Spektrum an Ingenieur-, Technik- und Beratungsdienstleistungen anbietet, die darauf abzielen, die betriebliche Effizienz, Compliance und Qualitätssicherung in den Biotechnologie- und Pharmasektoren zu verbessern. Ihre Expertise umfasst Bereiche wie Audits, regulatorische Angelegenheiten, Inbetriebnahme, Validierung und Projektmanagement, um Unternehmen bei der Risikominderung und Prozessoptimierung für erfolgreiche Ergebnisse in regulierten Umgebungen zu unterstützen.

Beschreibung

• Support system validation and product release processes • Ensure compliance with industry standards and regulatory requirements • Contribute to the development and improvement of validation procedures • Drive overall product excellence • Collaborate with cross-functional teams and external clients on project requirements • Conduct thorough testing for system functionality and reliability using a risk-based validation approach • Support planning, development, and implementation of computer systems validation documentation • Write and execute validation documentation, including requirements specifications, test scripts, summary reports, and trace matrices • Initiate and oversee system CSV change control requests and associated validation documentation • Identify and troubleshoot potential risks and implement required solutions • Participate in team meetings and provide project progress updates • Travel as needed for project assignments and client engagements • Perform additional responsibilities as required

🎯 Anforderungen

• Bachelor's degree in related engineering discipline • Entry-level position • Prior internship or project experience in computer systems/software testing and validation • Basic understanding of validation processes and risk-based approach • Familiarity with clinical trial software • Knowledge of the Software Development Cycle preferred • Excellent technical computer skills • Advanced technical writing skills • Familiarity with technical lifecycle documentation in regulated industries • Strong attention to detail and commitment to quality • Excellent communication and interpersonal skills • Excellent time management skills and ability to manage multiple projects effectively • Willingness and ability to travel as needed for project assignments and client engagements • Ability to adapt to different locations, cultures, and work environments • Must be authorized to work in U.S. • No C2C at this time

🏖️ Vorteile

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents • Insurance options for Employee Assistance Programs, Basic Life Insurance, Long Term Disability and more • 401(k) and 401(k) matching • PTO, Sick Time, and Paid Holidays • Education Assistance • Pet Insurance • Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more) • Financial Perks and Discounts • Compensation and benefits structure that rewards employees • Tools to help employees grow and learn • Coaching and professional development opportunities

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