• Execute validation activities adhering to industry standards and regulations including cGMP, FDA, GAMP5, etc.
• Draft and execute IQ, OQ, PQ protocols for required equipment and systems.
• Perform dry runs prior to execution.
• Collaborate with cross functional teams to ensure alignment and understanding of configuration specifications, SCADA configuration, functionality requirements, process controls, and so on.
• Review and approve drafted documentation to ensure compliance with regulatory standards and company policies.
• Execute computer system validation protocols.
• Conduct risk assessment and analysis, identifying potential risks and implementing mitigation strategies.
• Investigate deviations and implement corrective actions.
• Support equipment, instrumentation, and calibration testing.
• Communicate effectively with stakeholders to provide updates on validation progress, issues, and resolutions.
• Identify and implement continuous improvement opportunities to enhance the efficiency and effectiveness of validation processes.
• Additional responsibilities as required.

Requirements

• Bachelor’s degree in related engineering or scientific discipline.
• 3-5 years of CQV engineering experience in the pharmaceutical industry. Additional computer system validation experience is a plus.
• Extensive experience in drafting and executing validation protocols (IQ, OQ, and PQ).
• Strong understanding of configuration specifications, SCADA configuration, object and graphical configuration, functionality requirements, and process controls.
• Proven knowledge of automated manufacturing and processes.
• Strong understanding and experience with critical verifications.
• System validation experience including knowledge of PLCS, SCADA, HMIs, etc.
• Understanding and experience with user access levels and system security is a plus.
• Strong understanding of regulatory requirements and industry compliance standards including cGMP, GAMP5, ALCOA , etc.
• Experienced in risk management and deviation investigation.
• Excellent technical writing skills, with strong understanding of technical validation and system documentation.
• Knowledge of hardware and equipment for automation lines is a plus.
• Strong troubleshooting, analytical, and problem-solving skills.
• Knowledge of containment principles is a plus.
• Ability to examine and identify defects, inconsistencies, or irregularities in processes and results.
• Strong knowledge of quality procedures and protocols.
• Excellent communication skills both verbal and written.
• Excellent attention to detail, time-management, and organizational skills.
• Ability to handle multiple priorities at once and drive tight project deadlines.
• Strong collaborative and interpersonal skills.
• 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