Validation Engineer

PSC Biotech
Lewisville, TX Full Time
POSTED ON 8/4/2023 CLOSED ON 11/26/2023

What are the responsibilities and job description for the Validation Engineer position at PSC Biotech?



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 driven Validation Engineer with a background in cleaning and automation equipment. 

  • Develop and execute validation protocols for cleaning and automation equipment, adhering to industry standards, regulatory requirements, and company policies.
  • Perform risk assessments and identify critical parameters for validation testing to ensure equipment reliability and performance.
  • Ensure the timely and accurate documentation of validation activities, including test plans, protocols, reports, and standard operating procedures.
  • Conduct validation tests, including but not limited to functional testing, performance testing, stability testing, etc. as applicable.
  • Analyze and interpret validation data, ensuring compliance with acceptance criteria and quality standards.
  • Collaborate with cross-functional teams to maintain a culture of continuous improvement, focusing on efficiency, quality, and compliance.
  • Continuously identify opportunities for process optimization and improvement in production. 
  • Additional duties may be assigned. 


Requirements

  • Bachelor's degree in engineering or related. 
  • 3-5 years of Validation Engineering experience in the pharmaceutical, medical device, and/or biotech industries. 
  • Experience with cleaning and automation euipment such as kettles, packaging lines, fillers, etc. ​
  • Advanced knowledge of cGMP guidelines and industry standards and regulations. 
  • In-depth knowledge of validation principles, methodologies, and best practices.
  • Hands-on experience with validation activities, including test plan development, execution, and documentation.
  • Strong analytical and problem-solving skills with attention to detail.
  • Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams.
  • Demonstrated ability to work independently, manage multiple projects, and meet deadlines.
  • At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.



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 rate at Anytime Fitness
  • Financial Perks and Discounts


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.

#LI-RW1​

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