Engineering Change Management Lead

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 join our team, you will be inspired in your career, explore your professional passions, and work alongside people who will value and nurture your talents. We believe in coaching and developing the next industry leaders and influencers. As such, you will be offered a compensation and benefits structure that rewards you, along with tools to help you grow and learn. At PSC Biotech, it’s about more than just a job—it’s about your career and future. Your Role Define and measure success metrics and monitor change progress. Manage document control processes. Develop change management plans, define metrics, and identify risks. Create and support Corrective Action Plans. Assess change impact and communicate summaries. Maintain Quality Management System (experience with TrackWise preferred). Manage facilities, packaging, process equipment, and aseptic projects. Coordinate projects such as clean room modifications, equipment upgrades, and installations. Plan and monitor aseptic operations change control processes. Requirements Bachelor’s Degree in engineering or relevant field. Knowledge of ECM as defined by ISPE Baseline Guide 5. At least 2 years of experience in change control management or engineering. Experience in planning and executing Change Control processes in packaging/processing and clean room modifications. Familiarity with TrackWise. Experience with Vial Packaging Lines, Aseptic Fill Lines, Lyos, Parts Washers, and Autoclaves. Proficiency in ISO 8 and ISO 5 environments. Excellent communication skills, both verbal and written. Strong organizational and problem-solving skills. Good math and analytical abilities. Benefits PSC offers a comprehensive benefits package aimed at promoting work-life balance and employee well-being, including: Medical, Dental, and Vision insurance (PSC pays 100% of employee premiums and 50% of dependents). Additional insurance options including Employee Assistance, Life Insurance, and more. 401(k) plan with matching. PTO, sick leave, and paid holidays. Education Assistance. Pet Insurance and Fitness Benefits. Financial perks and discounts at qualifying gyms. Equal Opportunity Employment PSC is committed to Equal Employment Opportunity and complies with all applicable laws. We prohibit discrimination based on race, color, religion, sex, national origin, age, genetic information, or other protected statuses. #LI-TP1

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