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Validation Engineer

3 months ago

Thousand Oaks, United States PSC Biotech Full time
Job Description
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort 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 an experienced and motivated Validation Engineer to support commissioning and qualification activities of equipment, systems, facilities and utilities.
  • Generate and execute CQPs, IQs, OQs, PQs, test plans, timelines, reports, and identify any potential associated issues or discrepancies for a variety of equipment and systems.
  • Perform activities such as Cycle Development (CD, Design Qualification, Commissioning & Qualification, Performance Qualification (PQ),
  • Cleaning Validation (CV), and Validation Maintenance.
  • Support capital projects and departmental validation activities.
  • Manage or support all qualification execution and documentation reporting for fill lines, freezers, water systems, HVAC, CIP/SIP stations for tanks and filter units, vial washers, tunnel sterilizers, and other related/required facilities equipment and systems.
  • Generate and own all required documentation including but not limited to system assessments, URS, specifications, drawings, change control tasks and so on.
  • Support test case execution and corrective actions.
  • Work collaboratively with cross functional teams to drive project success and completion.
  • Effectively communicate action items, risks, etc. to stakeholders.
  • Additional responsibilities as required.
Requirements
  • Bachelor's degree in related engineering discipline.
  • 3 years or more of commissioning, qualification, and validation experience in the pharmaceutical industry.
  • Strong knowledge of industry regulations and standards.
  • Excellent technical writing skills.
  • Detail oriented and strong commitment to quality.
  • Excellent communication and interpersonal skills.
  • Strong organization and time management skills.
Benefits

Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
  • 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
  • Discounted Fitness Rates
  • Financial Perks and Discounts

Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $95,000 and $115,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

Equal Opportunity Employment Statement

PSC is committed to 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 aspects 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.

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