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Validation Project Coordinator

2 months ago

St Louis, Missouri, United States PSC Biotech Full time
Job Overview
PSC Biotech is dedicated to providing the life sciences sector with critical services that ensure health care products are developed, manufactured, and distributed to the highest standards while adhering to all relevant regulatory requirements.

Our mission is to elevate our clients' success, and you can contribute to our collective achievements. With a global team of skilled professionals and experts across strategically located offices in North America, Europe, Asia, and the Middle East, we take pride in the roles we have played in helping our clients succeed.

Professional Environment

At PSC Biotech, we are passionate about assembling the best and brightest talent from diverse backgrounds to create something exceptional. By joining our organization, you will have the opportunity to feel inspired in your career, pursue your professional interests, and collaborate with a team that values and nurtures your skills.

We are committed to mentoring and developing the next generation of industry leaders and influencers. You will receive a compensation and benefits package that rewards your contributions, along with the resources necessary for your growth and learning.

At PSC Biotech, your role transcends mere employment—it's about your career trajectory and future potential.

Your Responsibilities

We are seeking a seasoned Validation Project Manager. Ideal candidates will possess a robust technical background in equipment/system validation, complemented by exceptional communication, organizational, and project management skills. Responsibilities include:
  • Developing and executing validation plans, protocols, and reports for equipment, processes, and systems.
  • Generating and overseeing project deliverables, coordinating preventative maintenance, and mitigating risks.
  • Defining and tracking Key Performance Indicators (KPIs) to assess validation effectiveness and reporting findings to management and stakeholders.
  • Managing validation projects from inception to completion.
  • Collaborating with cross-functional teams to synchronize project timelines, plans, and deliverables.
  • Conducting dry-runs, reviewing, approving, and executing validation documentation.
  • Supporting overall engineering testing activities by creating, revising, and executing commissioning, validation, and SAT protocols.
  • Implementing and reviewing audit trails to ensure data integrity.
  • Providing ongoing support and technical expertise throughout validation execution and qualification processes.
  • Configuring hardware, objects, SCADA systems, and field networks.
  • Conducting risk assessments and identifying potential risks, recommending areas for improvement.
  • Documenting and managing deficiencies and deviations.
  • Implementing CAPA to address issues and prevent recurrence.
  • Performing risk assessments to identify critical process parameters and developing mitigation strategies.
  • Ensuring all validation activities comply with FDA, EMA, GAMP 5, and other relevant regulatory bodies.
  • Additional responsibilities as required.

Qualifications
  • Bachelor's degree in a relevant engineering discipline.
  • 5+ years of validation engineering experience with equipment and computer systems (CSV) in the pharmaceutical/life science sector.
  • Experience with paperless validation, preferably using ValGenesis.
  • Demonstrated success in managing, reviewing, authoring, and approving comprehensive technical documentation.
  • Experience generating and executing validation activities across various equipment and systems.
  • Proven track record in project coordination and management, with the ability to effectively communicate and align team members while developing project plans.
  • Experience in vendor coordination.
  • Excellent technical writing capabilities.
  • Strong understanding of industry regulations and requirements.
  • Meticulous attention to detail and a commitment to quality and compliance.
  • Strong problem-solving and analytical skills.
  • Willingness to travel as needed for project assignments and client engagements, adapting to different locations, cultures, and work environments to facilitate effective collaboration with clients and colleagues.

Compensation and Benefits
PSC Biotech offers a comprehensive benefits package, reflecting our commitment to investing in our employees who enable our company to fulfill its mission and achieve success. We strive to promote a healthy work-life balance, ensuring you enjoy your work while having the time and resources to lead a fulfilling life.

Benefits include:
  • Medical, Dental, and Vision coverage, with PSC covering 100% of 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) plan with matching contributions.
  • Paid Time Off, Sick Leave, and Paid Holidays.
  • Education Assistance programs.
  • Pet Insurance options.
  • Fitness Benefits, including membership discounts and other perks at qualifying gyms.

Equal Opportunity Employment Statement:

PSC is committed to a policy of Equal Employment Opportunity concerning all employees, interns, and applicants for employment. Our policy is to comply with all applicable federal, state, and local laws regarding employment discrimination. The Company prohibits discrimination against qualified employees, interns, and applicants in all aspects of employment, including recruitment, hiring, evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, working conditions, termination, and employer-sponsored activities. 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.