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Software Validation Specialist
2 months ago
About PSC Biotech
PSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.
Our Mission
We strive to empower our clients' success by delivering exceptional services and solutions that meet the evolving needs of the life sciences industry.
The Role
We are seeking an experienced Computer Systems Validation Engineer to drive system and software validation processes, ensuring compliance with industry regulations.
Key Responsibilities
- Develop and execute validation and qualification protocols for required software systems, ensuring compliance with industry regulations.
- Gather user requirements for required software systems, collaborating with cross-functional teams to ensure requirements are met.
- Implement data integrity requirements, executing data integrity qualifications, and proactively resolving any potential risks/issues.
- Ensure proper user access controls are in place. Conduct regular reviews of user access and activity.
- Document and report all required validation activities.
- Perform risk assessments and impact analyses.
- Support continuous improvement initiatives.
Requirements
- Bachelor's degree in a related engineering discipline.
- 2-5+ years of experience in Computer System Validation and Software Validation in the life sciences industry.
- Experienced and strong knowledge of Empower systems.
- Knowledge of data integrity principles and practices.
- Knowledge of risk management and impact analysis.
- Advanced understanding of regulatory requirements.
- Excellent technical writing skills.
- Excellent problem-solving and analytical skills.
- Strong communication, interpersonal, and collaboration skills.
What We Offer
PSC Biotech is committed to providing a dynamic and supportive work environment that fosters growth and development. We offer a competitive compensation and benefits package, as well as opportunities for professional growth and advancement.
Equal Opportunity Employment Statement
PSC Biotech is an equal opportunity employer, committed to a policy of equal employment opportunity with respect to all employees, interns, and applicants for employment. We prohibit discrimination against qualified employees, interns, and applicants in all aspects of employment, including recruitment, interviewing, hiring, evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination, and employer-sponsored activities and programs.
