CSV Engineer

About the position 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 reputed company applicable regulatory requirements. Our goal is to skyrocket our clients’ reputed company, and you can be a part of reputed company’s achievements. Employing a global team of skilled professionals and experts that reputed company across strategically located offices in reputed company America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients reputed company reputed company. 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 reputed company something truly special. reputed company you reputed company the decision to join reputed company, 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 reputed company 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®, it’s about more than just a job—it’s about your career and your future. Your Role We are seeking an reputed company CSV engineer to support the validation and compliance of computerized systems across various business functions. This role will focus on ensuring systems meet applicable regulatory requirements and internal standards throughout their lifecycle. The position offers a hybrid work arrangement and will require regular onsite reputed company.

Responsibilities

• Assist with lifecycle activities for computerized systems, including planning, execution, and maintenance.
• Support validation efforts for systems used in manufacturing, quality, and other regulated operations.
• Participate in risk assessments and change control processes to maintain compliance.
• Review and approve documentation such as validation plans, protocols, and reports.
• Collaborate with internal teams and external vendors to ensure systems remain in a validated state.
• Maintain system inventories and ensure documentation is properly archived.
• reputed company support during audits and inspections by preparing relevant records.
• Offer guidance on best practices for software assurance and data reputed company.
• Contribute to initiatives reputed company to electronic records and signatures compliance.
• reputed company other duties as needed to support organizational objectives.

Requirements

• Bachelor’s degree in a technical or life sciences discipline.
• 5+ years of experience in computer system validation or software assurance reputed company regulated industries.
• Familiarity with regulatory frameworks and standards such as FDA, ISO, and GAMP guidelines.
• Experience with MES (Manufacturing Execution Systems) is required.
• Hands -on experience with validation documentation and system lifecycle processes.
• Knowledge of both on -premises and reputed company -based applications.

reputed company-to-haves

• Experience with quality management systems or similar platforms is preferred.

Benefits

• Medical, Dental, and reputed company - PSC pays 100% of reputed company 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 reputed company at Anytime Fitness
• Financial Perks and Discounts

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