Validation Engineer

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Summary:

• To execute validation activities in compliance with regulatory requirements and company standards. The Validation Engineer supports the Validation Team Lead in implementing the Validation Master Plan, maintaining validation-related SOPs, and performing validation for processes, cleaning, equipment, analytical instruments, and utilities.
  
  

Requirements

Responsibilities:

As our Validation Engineer, your key responsibilities will be as follows:

Develop, execute, and document validation protocols and reports for process, cleaning, equipment, analytical instruments, and utilities.

Ensure validation activities comply with GMP, regulatory guidelines, and internal procedures.

Support technology transfers and new product introductions through validation activities.

Maintain accurate and complete validation documentation in accordance with SOPs and regulatory requirements.

Assist in updating and implementing validation-related SOPs under the guidance of the Validation Team Lead.

Ensure validation records are audit-ready and support internal and external inspections.

Identify opportunities to improve validation processes and enhance efficiency.

Contribute to initiatives that align validation practices with evolving regulatory expectations.

Work closely with manufacturing, quality, engineering, and analytical teams to coordinate validation activities.

Provide technical support during troubleshooting and investigations related to validation.

Qualifications and Experience:

• Degree in Engineering, Pharmaceutical Science, or related discipline.
  
• 2–4 years in validation within a GMP-regulated environment.
  
• Experience in process, cleaning, and equipment validation preferred.
  

Skills and Competencies:

• Strong understanding of GMP and validation principles.
  
• Excellent documentation and organizational skills.
  
• Ability to work collaboratively across functions.
  
• Solid knowledge of validation methodologies and regulatory requirements.
  
• Ensures accuracy and completeness in validation documentation.
  
• Ability to troubleshoot and resolve validation-related issues.
  
• Works effectively with cross-functional teams.
  
• Commitment to maintaining high standards of quality and regulatory compliance.