Validation Engineer I

This is a remote position.

About the Company

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 team’s 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.

With operations spanning the globe and featuring a multicultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you 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.

About the Role

We are hiring a Validation Engineer I to support system validation and product release processes, ensuring compliance with industry standards and regulatory requirements. You will play a key role in contributing to the development and improvement of validation procedures and driving overall product excellence. This is an entry-level, remote position.

Successful candidates have a bachelor’s degree within an engineering discipline, a passion for technology, and exposure to system/software testing in the life science industry.

Responsibilities

• Collaborate with cross-functional teams and external clients to ensure alignment on project requirements.
• Conduct thorough testing to ensure system functionality and reliability, utilizing a risk-based validation approach.
• Support the planning, development, and implementation of computer systems validation documentation.
• Write and execute required validation documentation including requirements specifications, test scripts, summary reports, trace matrices, etc.
• Initiate and oversee system CSV associated change control requests and associated validation documentation.
• Identify and troubleshoot any potential risks and effectively implement required solutions.
• Ensure compliance with industry standards and regulatory requirements.
• Participate in team meetings and provide updates on project progress.
• Additional responsibilities as required.

Requirements

• Bachelor's degree in a related engineering discipline.
• This is an entry-level position.
• Prior internship or project experience within computer systems/software testing and validation.
• Basic understanding of validation processes and risk-based approach.
• Familiar with clinical trial software.
• Knowledge of the Software Development Cycle is preferred.
• Excellent technical computer skills.
• Advanced technical writing skills, and familiar with technical lifecycle documentation in regulated industries.
• Strong attention to detail with a commitment to quality.
• Excellent communication and interpersonal skills.
• Excellent time management skills with the ability to manage multiple projects effectively.
• Willing and able to travel as needed for project assignments and client engagements.
• Must be authorized to work in the U.S.

No C2C at this time.

Benefits

• 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.

Pay

The hourly bracket for this role is set between $20 - $23. The pay offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.