Validation Project Manager

4 hours ago

Thousand Oaks, California, United States PSC Biotech Full time
Job Overview

PSC Biotech is a leading provider of life sciences services, ensuring the highest standards of product development, manufacturing, and distribution in compliance with regulatory requirements.

We are seeking a highly skilled Validation Project Lead to join our team, responsible for managing validation projects and ensuring compliance with industry regulations and quality standards.

Key Responsibilities
  • Collaborate with cross-functional teams to create and maintain project plans, scope, requirements, and timelines.
  • Host project meetings to provide status updates to stakeholders and team members.
  • Effectively communicate project findings, risks, and corrective action plans to stakeholders.
  • Assess deviations and identify areas for improvement and associated action items.
  • Conduct thorough technical evaluations of equipment and systems, identifying acceptance criteria, potential risks, and troubleshooting.
  • Develop, review, and redline Piping and Instrumentation Diagrams (P&IDs), ensuring compliance with industry standards and regulations.
  • Prepare and maintain detailed project documentation, including reports, risk assessments, validation protocols, and more.
  • Collaborate with vendors for equipment/system requirements and compliance with project specifications.
  • Assist with project closeouts and provide summaries/feedback for proposed process changes.
  • Provide ongoing technical guidance, support, and execution throughout required CQV and related projects.
Requirements
  • Bachelor's Degree in a related engineering discipline.
  • 5-10 years of validation project management experience in the pharmaceutical/biotech industry.
  • Highly skilled in drafting, reviewing, and redlining P&IDs.
  • AutoCAD experience is a plus.
  • Strong understanding of industry regulations and quality standards.
  • Strong understanding of validation lifecycle in cGMP environments.
  • Proven experience with asset management systems.
  • Computer and technical software proficiency.
  • Strong analytical and problem-solving abilities.
  • Effective communication and interpersonal skills.
  • Excellent attention to detail and commitment to quality and compliance.
  • Ability to work independently and manage multiple priorities.
Benefits
  • 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, Short/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).
  • Financial Perks and Discounts.

The salary bracket for this role is set between $85,000 - $125,000 annually, with adjustments based on qualifications, skills, and experience.

PSC Biotech is an equal opportunity employer, committed to a policy of equal employment opportunity and compliance with all applicable federal, state, and local laws concerning employment discrimination.

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