CSV Engineer

Winston Salem, NC - USA

Monthly Salary: Not Disclosed

Experience Required: 3-5years

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients success and you can be a part of our teams achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America Europe Asia and the Middle East we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.

At PSC Biotech its about more than just a jobits about your career and your future.

Your Role

We are hiring an experienced Computer Systems Validation Engineer. The CSV Engineer will play a critical role in ensuring that all systems are validated and compliant with regulatory standards. This role involves planning writing implementing and executing CSV protocols to ensure that our systems operate as intended and meet all regulatory requirements.

Collaborate with project stakeholders and cross-functional teams to define project requirements and ensure validation documentation aligns with system specifications.
Perform execution of CSV protocols including Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) and User Acceptance Testing (UAT).
Write review and maintain validation protocols and reports to ensure compliance with required GxP and 21 CFR Part 11 regulations.
Participate in the planning development and implementation of computer systems validation documentation with a focus on writing protocols and lifecycle management.
Manage and validate protocols electronic records and electronic signatures ensuring data integrity and compliance.
Ensure seamless integration of equipment as required.
Initiate and oversee system CSV-associated change control requests and associated validation documentation.
Troubleshoot and resolve issues related to validated systems working closely with internal teams to implement corrective actions.
Additional responsibilities as assigned to drive project success.

Requirements

Bachelors degree in Engineering Computer Science or a related field.
35 years of computerized system validation experience within the life sciences/pharmaceutical industries.
Strong knowledge of validation of cGxP computerized systems within FDA-regulated environments.
Strong understanding of industry standards and best practices for computer validation.
Proficiency in writing and reviewing validation protocols data integrity testing and compliance.
Experience with Enterprise Systems is required.
Experience with equipment and system integration.
Strong analytical skills with the ability to think critically and solve problems effectively.
Excellent written and verbal communication skills.
Strong time management and organizational abilities.
Detail-oriented mindset with a commitment to maintaining high-quality standards.

Benefits

Offering a full suite of benefits PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy.

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 Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO Sick Time and Paid Holidays
Education Assistance
Pet Insurance
Discounted rate at Anytime Fitness
Financial Perks and Discounts

Equal Opportunity Employment Statement

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) 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 including wellness social and recreational programs. Employment decisions will be made without regard to an applicants employees or interns actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.

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