Validation Project Coordinator

2 weeks 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, 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 play to help our clients thrive.

Experience and Culture

At PSC Biotech, we value a multi-cultural team and are passionate about uniting the best talents to create something exceptional. By choosing to be part of our organization, you will have the opportunity to feel inspired in your career, pursue your professional interests, and collaborate with individuals who appreciate and nurture your skills.

We are committed to mentoring and developing the next generation of industry leaders. As such, you will receive a compensation and benefits structure that rewards your contributions while providing you with the tools necessary for growth and learning.

At PSC Biotech, your career and future are our priorities.

Your Responsibilities

We are seeking a seasoned Validation Project Manager. Ideal candidates will possess a robust technical background in equipment/system validation, along with exceptional communication, organizational, and project coordination skills. Key responsibilities include:
  • Developing and executing validation plans, protocols, and reports for equipment, processes, and systems.
  • Generating and managing project deliverables, coordinating preventative maintenance, and mitigating risks.
  • Defining and monitoring Key Performance Indicators (KPIs) to assess validation effectiveness and reporting on KPIs to management and stakeholders.
  • Overseeing validation projects from inception to completion.
  • Collaborating with cross-functional teams to synchronize project schedules, plans, and deliverables.
  • Conducting dry-runs, reviewing, approving, and executing validation documentation.
  • Supporting overall engineering testing activities by developing, 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 activities.
  • Configuring hardware, objects, SCADA systems, and field networks.
  • Conducting risk analyses and identifying potential risks, while 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 necessary.

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 in paperless validation, preferably with ValGenesis.
  • Proven track record in managing, reviewing, authoring, and approving full lifecycle technical documentation.
  • Experience generating and executing validation activities across various equipment and systems.
  • Demonstrated success in project coordination and management responsibilities, 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 collaborate effectively with clients and colleagues.

Benefits
PSC Biotech offers a comprehensive suite of benefits, firmly focused on investing in our employees who enable our company to fulfill its mission and achieve success. We promote a healthy work-life balance, ensuring you enjoy your work while having the time and resources to live a fulfilling life.

Benefits include:
  • Medical, Dental, and Vision coverage - PSC pays 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.
  • PTO, Sick Time, and Paid Holidays.
  • Education Assistance.
  • Pet Insurance.
  • Fitness Benefits, including membership discounts and other perks at qualifying gyms.
  • Financial Perks and Discounts.

Equal Opportunity Employment Statement:

PSC is committed to a policy of Equal Employment Opportunity for all employees, interns, and applicants. Our policy is to comply with all applicable federal, state, and local laws concerning employment discrimination. We prohibit discrimination against qualified individuals in all aspects of employment, including recruitment, hiring, evaluation, compensation, promotion, job assignment, training, and benefits.

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