Validation Engineer

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 multicultural 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 Validation Engineer to drive project success and support the development and execution of commissioning qualification and validation protocols for a range of equipment and systems. Successful candidates should have a strong background and experience working with HVAC systems and strong knowledge of risk based approaches in the pharmaceutical industry.

• Proactively support commissioning qualification and validation activities. Develop and implement comprehensive validation plans.
  
• Develop and execute CQV protocols for required equipment facilities utilities systems and processes ensuring compliance with regulatory requirements and industry standards.
  
• Develop and execute validation protocols for required HVAC systems including IQ OQ PQ. Conduct thorough risk assessment related to HVAC system validation.
  
• Investigate and troubleshoot HVAC system deviations ensuring timely resolution and documentation of corrective actions.
  
• Write review and approve technical CQV documentation including standard operating procedures validation plans execution plans risk assessments summary reports URS FRS design specifications testing protocols and so on.
  
• Conduct risk assessments to identify and mitigate potential validation risks. Support investigations deviations and change control processes.
  
• Collaborate with crossfunctional teams to ensure alignment on project deliverables and timelines.
• Additional responsibilities as assigned.
  

Requirements

• Bachelors Degree in related engineering discipline.
  
• 35 years of handson commissioning qualification and validation engineering experience in the pharmaceutical/life science industry.
  
• HVAC system experience is required.
  
• KNEAT system experience is highly preferred.
  
• Strong technical writing skills experienced writing and executing validation protocols reports etc.
  
• Advanced understanding of validation principles and riskbased approaches.
• Strong knowledge of regulatory requirements and industry standards (cGMP GDP FDA EMA etc.)
  
• Proficiency in risk assessment methodologies and root cause analysis.
  
• Strong analytical and problemsolving skills with a meticulous attention to detail.
  
• Excellent communication and interpersonal skills.
  
• Ability to work independently and collaboratively in a fastpaced environment.
  
• 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.
  

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 employersponsored 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.

#LIRW1

Bachelor's Degree in related engineering discipline. 3-5 years of hands-on commissioning, qualification, and validation engineering experience in the pharmaceutical/life science industry. HVAC system experience is required. KNEAT system experience is highly preferred. Strong technical writing skills, experienced writing and executing validation protocols, reports, etc. Advanced understanding of validation principles and risk-based approaches. Strong knowledge of regulatory requirements and industry standards (cGMP, GDP, FDA, EMA, etc.) Proficiency in risk assessment methodologies and root cause analysis. Strong analytical and problem-solving skills, with a meticulous attention to detail. Excellent communication and interpersonal skills. Ability to work independently and collaboratively in a fast-paced environment. 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. 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