Validation Engineer I

PSC Biotech; Northern (KY); Hybrid; USD 42,000 - 48,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) plan

PTO/Sick Time/Holidays

Education Assistance

Pet Insurance

Fitness benefits

Job summary

PSC Biotech is hiring an Entry-Level Validation Engineer I to support system validation and product release processes, ensuring regulatory compliance. The role emphasizes development of validation procedures, execution of test scripts, and change control documentation within a fully remote setup.

Ideal candidates hold a bachelor’s degree in an engineering discipline, with exposure to system/software testing in the life sciences.

Qualifications

• Entry-level position requiring a bachelor's degree in an engineering discipline.
• Prior internship or project experience in computer systems/software testing and validation is preferred.
• Basic understanding of validation processes and risk-based approaches.
• Familiarity with clinical trial software.
• Knowledge of the Software Development Life Cycle is preferred.
• Advanced technical writing skills and experience with lifecycle documentation in regulated industries.

Responsibilities

• Collaborate with cross-functional teams and external clients to align on project requirements.
• Conduct thorough testing to ensure system functionality and reliability using a risk-based validation approach.
• Support planning, development, and implementation of computer systems validation documentation.
• Write and execute validation documents including requirements specs, test scripts, and trace matrices.
• Initiate and manage CSV-related change control requests and related validation documentation.
• Identify and troubleshoot risks and implement solutions to maintain compliance with standards.
• Participate in team meetings and provide project progress updates.

Skills

Communication skills

Time management

Attention to detail

Technical writing

Interpersonal skills

Travel willingness

Education

Bachelor's degree in engineering

Tools

Clinical trial software

Software Development Life Cycle

Job description

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®, it’s about more than just a job—it’s about your career and your future.

Your Role

We are hiring a Validation Engineer I to join our team! This position will 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.

• 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 projects progress.
• Additional responsibilities as required.

Requirements

• Bachelor\'s degree in 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.
• 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.
• At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
• Must be authorized to work in U.S.
• No C2C at this time.

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, 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

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.

Equal Opportunity Employment Statement

PSC Biotech 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 applicant’s, employee’s, or intern’s 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.