Senior Validation Engineer

4 weeks ago

india 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 a Senior Validation Engineer. The Senior Engineer should have an advanced background in the commissioning, qualification, and validation of laboratory equipment, facility systems, and utilities. 
  • Lead the development and execution of commissioning, qualification, and validation protocols for a range of laboratory equipment, facility systems, and utilities. 
  • Draft, review, author, and deploy all required validation documentation including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, and so on. 
  • Provide technical expertise throughout the validation lifecycle including risk assessment, deviation investigation, and change control activities. 
  • Effectively identify potential risks and areas of improvement and proactively implement risk mitigation.
  • Document test results, deviations, and investigations in compliance with company procedures and regulatory standards.
  • Perform temperature mapping studies for controlled environments, lab spaces, warehouses, CTUs, etc. leading all test activities, report generation, and improvement initiatives. 
  • Collaborate with cross functional teams to support all project timelines and deliverables, and be able to drive successful validation of critical systems and equipment. 
  • Contribute to the continuous improvement of validation processes and procedures.
  • Ensure compliance with industry regulations and requirements at all times.
  • Additional responsibilities as required.

Requirements
  • Bachelor's degree in related engineering discipline. 
  • 7-10 years of commissioning, qualification, and validation execution experience in the pharmaceutical/life science industry. 
  • Extensive knowledge and experience executing validation protocols and procedures for a range of laboratory equipment, facilities, and utilities. 
  • Experienced with paperless validation systems (ValGenesis, KNEAT, etc.).
  • Project Management experience is a plus. 
  • Experience leading validation projects from start to finish. 
  • Experienced in temperature mapping procedures and activities.
  • Strong knowledge of controlled systems.
  • Strong background in risk-based validation approaches. 
  • Strong understanding of regulatory requirements including cGMP, FDA, etc. 
  • Strong analytical skills with the ability to problem-solve and troubleshoot effectively.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.
  • Detail-oriented mindset with a commitment to maintaining high-quality standards.
  • 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.
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Requirements
Bachelor's degree in related engineering discipline. 7-10 years of experience as a CQV Engineer in the pharmaceutical/life science industry. Extensive knowledge and experience executing validation protocols and procedures for a range of laboratory equipment, facilities, and utilities. Experience leading validation projects from start to finish. Experienced in temperature mapping procedures and activities. Strong knowledge of controlled systems. Strong background in risk-based validation approaches. Strong understanding of regulatory requirements including cGMP, FDA, etc. Strong analytical skills with the ability to problem-solve and troubleshoot effectively. Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment. Detail-oriented mindset with a commitment to maintaining high-quality standards. 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.

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