Job Details

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

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together 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 Project Engineer to deliver comprehensive support throughout every stage of the CQV lifecycle. This role offers guidance in project coordination, strategic development, and execution, to ensure adherence to regulatory standards and the highest levels of product safety.

Responsibilities

• Lead and coordinate engineers and contractors throughout project execution.
• Coordinate commissioning and startup of new equipment, utilities, and cleanroom systems.
• Develop and approve IQ/OQ/PQ protocols for newly installed systems and equipment.
• Prepare, review, and maintain documentation, including validation protocols, plans, reports, and SOPs.
• Ensure timely execution of PPQ testing and validation deliverables.
• Coordinate with vendors and contractors to support hand-offs and system turnover.
• Ensure compliance with regulatory requirements (FDA, EMA) and industry standards (GMP, GAMP).
• Provide technical oversight during validation execution and qualification activities.
• Additional responsibilities as required.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 4-5 years of project experience in pharmaceutical and/or biotech industries.
• Proven experience coordinating CQV activities during new facility build outs, including equipment installation and startup.
• Familiarity with project execution and project management tools (MS Project, Smartsheet).
• Understanding of regulatory requirements and industry standards.
• Knowledge of validation lifecycle.
• Strong technical writing skills and experience with validation documentation (protocols, reports, procedures).
• Effective communication and interpersonal skills.
• Organized, proactive, and detail-oriented with a commitment to quality and compliance.
• Must be authorized to work in the U.S.
• No C2C at this time.

Benefits

W2 Temp positions include our medical and sick time benefits.

Equal Opportunity Employment Statement

PSC 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 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.

Seniority level: Mid-Senior level

Employment type: Temporary

Job function: Engineering and Information Technology

Location: Columbus, OH

Salary: $75,000 - $80,000