CSV 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 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 RoleWe are seeking a highly skilled and experienced CSV Engineer to join our team in Durham, NC. Develop and execute validation plans, protocols, and reports for computerized systems and commissioning and qualification documents used in pharmaceutical manufacturing, ensuring compliance with FDA regulations (21 CFR Part 11), GxP, and other relevant guidelines. Manage and validate DeltaV systems, including configuration, change management, and troubleshooting to ensure reliable and efficient operation in a GMP environment. Perform risk assessments and impact analyses on computer systems to determine the extent of validation required and ensure that systems are appropriately controlled and documented. Maintain accurate and detailed validation documentation, including URS (User Requirements Specifications), FRS (Functional Requirements Specifications), DS (Design Specifications), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) documents. Ensure compliance with all relevant regulatory requirements, guidelines, and standards, including FDA, EMA, and ICH guidelines. Work closely with cross-functional teams, including Quality Assurance, Manufacturing, IT, and Engineering, to ensure that validation activities are integrated into project timelines and deliverables. Identify opportunities for continuous improvement in validation processes and methodologies to enhance efficiency, effectiveness, and compliance. Additional responsibilities as required. Requirements Bachelor's degree in related engineering discipline. 5-12 years of experience in CSV engineering in the pharmaceutical industry. Proficiency in DeltaV, including configuration, programming, and troubleshooting. Strong understanding of computer system validation principles, practices, and regulatory requirements. In-depth knowledge of FDA regulations and GxP, and other relevant industry standards and guidelines. Excellent problem-solving and analytical skills, with a keen attention to detail. Ability to work effectively both independently and as part of a multidisciplinary team. 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. BenefitsOffering 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 dependentsInsurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.401(k) and 401(k) matchingPTO, Sick Time, and Paid HolidaysEducation AssistancePet InsuranceFitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).Financial Perks and DiscountsEqual 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.