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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 essential services in the life sciences sector, ensuring that healthcare products are developed, manufactured, and distributed in accordance with the highest standards and regulatory requirements.

Our Mission
We aim to elevate our clients' success through a global team of skilled professionals across strategically located offices worldwide. We take pride in our contributions to our clients' achievements.

Experience and Culture
At PSC Biotech, we value diversity and the collaboration of a multi-cultural team. Joining us means being part of an inspiring environment where you can explore your professional interests and work with individuals who appreciate and nurture your skills.

We are committed to mentoring the next generation of industry leaders. As part of our team, you will receive a competitive compensation package and the resources necessary for your professional growth.

Your Responsibilities
We are seeking a qualified Validation Project Manager. Ideal candidates will possess a robust technical background in equipment/system validation, alongside exceptional communication, organizational, and project management skills. Key responsibilities include:
  • Developing and executing validation plans, protocols, and reports for various systems and processes.
  • Managing project deliverables, coordinating preventative maintenance, and mitigating risks.
  • Defining and tracking Key Performance Indicators (KPIs) to assess validation effectiveness and reporting findings to management.
  • Overseeing validation projects from initiation through to completion.
  • Collaborating with cross-functional teams to ensure alignment on project timelines and deliverables.
  • Conducting dry-runs and reviewing validation documentation.
  • Supporting engineering testing activities by creating and executing commissioning and validation protocols.
  • Implementing audit trails to maintain data integrity.
  • Providing ongoing technical support during validation and qualification processes.
  • Configuring hardware and systems as needed.
  • Conducting risk assessments and recommending improvements.
  • Documenting and managing any deficiencies or deviations.
  • Implementing corrective actions to resolve issues and prevent recurrence.
  • Ensuring compliance with FDA, EMA, GAMP 5, and other relevant regulatory standards.
  • Performing additional duties as required.

Qualifications
  • Bachelor's degree in a relevant engineering discipline.
  • Minimum of 5 years of experience in validation engineering within the pharmaceutical or life sciences sector.
  • Familiarity with paperless validation processes, preferably using ValGenesis.
  • Proven track record in managing and authoring comprehensive technical documentation.
  • Experience in executing validation activities across a variety of equipment and systems.
  • Strong project management skills with the ability to communicate effectively and coordinate team efforts.
  • Experience in vendor management.
  • Excellent technical writing capabilities.
  • Thorough understanding of industry regulations and compliance requirements.
  • Attention to detail and a commitment to quality.
  • Strong analytical and problem-solving skills.
  • Willingness to travel for project assignments and client interactions, adapting to diverse environments and cultures.

Benefits
PSC Biotech offers a comprehensive benefits package, emphasizing our commitment to employee well-being and work-life balance. Benefits include:
  • Medical, Dental, and Vision coverage with significant employer contributions.
  • Insurance options including Employee Assistance Programs and Disability coverage.
  • 401(k) plan with matching contributions.
  • Paid Time Off, Sick Leave, and Holidays.
  • Education Assistance programs.
  • Pet Insurance and Fitness Benefits.
  • Financial perks and discounts.

Equal Opportunity Employment Statement:
PSC Biotech is committed to a policy of Equal Employment Opportunity, ensuring that all employment decisions are made without regard to race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by law.