PSC Biotech® Corporation
Engineering Change Management Lead
PSC Biotech® Corporation, Minneapolis, Minnesota, United States, 55400
Overview
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 support our clients’ success through a global team of skilled professionals with 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. At PSC Biotech, it’s about more than just a job—it’s about your career and your future. Your Role
Define and measure success metrics and monitor change progress Document control management Develop change management plans, define metrics, and identify risks Create and support Corrective Action Plans Assess change impact and communicate summary of impact Maintain Quality Management System (experience with TrackWise is preferred) Manage various facilities, packaging and process equipment, and aseptic operation projects Coordinate and execute all other projects (may include clean room/classified area modifications, equipment upgrades/modifications, equipment installation, etc.) Plan, coordinate, and monitor aseptic operations change control processes (i.e. aseptic operations, ISO 8 operations, hydration, filling, and component preparation) Requirements
Bachelor’s Degree in engineering or another relevant field Knowledge and experience with ECM defined by ISPE Baseline guide 5 2 plus years of experience in change control management and/or engineering Well-versed in planning, coordinating, and executing Change Control processes (specifically in packaging/processing and clean room area modifications) Familiarity with TrackWise Advanced experience with Vial Packaging Lines, Solid Dose Lines, Aseptic Fill Lines, Lyos (freeze dryers), Parts Washers, and Autoclaves Proficient in ISO 8 and ISO 5 Exceptional communication skills (verbal and written) Strong organizational and problem-solving skills Excellent math and analytical abilities Benefits
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 Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more). Financial Perks and Discounts Equal Opportunity Employment
PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. We comply with all applicable federal, state and local laws concerning employment discrimination. Employment decisions will be made without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, or any other status protected by law. Seniority and Job Details
Seniority level: Entry level Employment type: Full-time Job function: Engineering and Information Technology
#J-18808-Ljbffr
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 support our clients’ success through a global team of skilled professionals with 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. At PSC Biotech, it’s about more than just a job—it’s about your career and your future. Your Role
Define and measure success metrics and monitor change progress Document control management Develop change management plans, define metrics, and identify risks Create and support Corrective Action Plans Assess change impact and communicate summary of impact Maintain Quality Management System (experience with TrackWise is preferred) Manage various facilities, packaging and process equipment, and aseptic operation projects Coordinate and execute all other projects (may include clean room/classified area modifications, equipment upgrades/modifications, equipment installation, etc.) Plan, coordinate, and monitor aseptic operations change control processes (i.e. aseptic operations, ISO 8 operations, hydration, filling, and component preparation) Requirements
Bachelor’s Degree in engineering or another relevant field Knowledge and experience with ECM defined by ISPE Baseline guide 5 2 plus years of experience in change control management and/or engineering Well-versed in planning, coordinating, and executing Change Control processes (specifically in packaging/processing and clean room area modifications) Familiarity with TrackWise Advanced experience with Vial Packaging Lines, Solid Dose Lines, Aseptic Fill Lines, Lyos (freeze dryers), Parts Washers, and Autoclaves Proficient in ISO 8 and ISO 5 Exceptional communication skills (verbal and written) Strong organizational and problem-solving skills Excellent math and analytical abilities Benefits
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 Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more). Financial Perks and Discounts Equal Opportunity Employment
PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. We comply with all applicable federal, state and local laws concerning employment discrimination. Employment decisions will be made without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, or any other status protected by law. Seniority and Job Details
Seniority level: Entry level Employment type: Full-time Job function: Engineering and Information Technology
#J-18808-Ljbffr