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 ExperienceWith 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 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 RoleAs a Senior CQV Engineer, you will spearhead commissioning, qualification, and validation efforts for pharmaceutical facilities, utilities, equipment, and systems. In this role, you'll take the lead in project planning, execution, and ensuring operational readiness of capital projects, contributing directly to our clients' success.Key responsibilities include:Managing project priorities, schedules, and budgets while proactively addressing risks and challenges.Designing and implementing CQV protocols for equipment and systems to meet compliance and performance standards.Creating and maintaining thorough documentation, including validation protocols, plans, reports, and SOPs.Assessing and mitigating risks associated with CQV processes.Diagnosing and resolving issues related to equipment and process functionality.Collaborating with cross-functional teams to streamline CQV activities and maintain alignment with project goals.Acting as a key liaison between vendors and contractors, ensuring seamless transitions and hand-offs.Upholding compliance with regulatory bodies (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).Providing technical expertise and ongoing support throughout validation and qualification phases.Taking on additional duties as needed to support project success.RequirementsBachelor’s degree in engineering or a related discipline.At least 7 years of CQV experience in the pharmaceutical or biotech sector.Hands-on knowledge of laboratory equipment, including freezers, refrigerators, water skids, and scales.Expertise in validating aseptic environments, temperature-controlled units, and environmental monitoring performance qualifications.Background in CQV processes for facilities and utilities such as air compressors, boilers, chillers, clean steam generators, WFI, and HVAC systems.Demonstrated success in leading CQV projects, with experience managing schedules, resources, and budgets.Deep understanding of regulatory compliance and industry best practices.Skilled in validation lifecycle management and risk-based methodologies.Proficient in CQV project lifecycle execution, from initiation through closeout.Strong analytical and problem-solving abilities, with a strategic approach to risk resolution.Excellent technical writing skills with knowledge of documentation requirements, including protocols, reports, risk assessments, and specifications.Effective communicator and collaborator, with experience managing stakeholder interactions.Highly organized and proactive in driving tasks forward.Detail-oriented with an unwavering commitment to quality and compliance.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 and more.401(k) and 401(k) matchingPTO, Sick Time, and Paid HolidaysEducation AssistancePet InsuranceDiscounted rate at Anytime FitnessFinancial Perks and DiscountsEstimated annual salary (dependent on experience) $100,000 – $130,000Equal Opportunity Employment StatementPSC 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 ’s actual or perceived: , color, , (including , , and ), , age (40 or older), , genetic information, or any other status protected by law.#LI-RD1 #J-18808-Ljbffr