Cyprotex
Senior GMP Compliance Specialist- site based, Redmond, WA
Cyprotex, Seattle, Washington, us, 98127
Overview
Job Title:
Senior GMP Compliance Specialist Shifts:
Days, Monday to Friday. 8:00am till 5:00pm, 8 hours, some flexibility. About Us:
this is who we are At
Just
Evotec Biologics , we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We\'re on a mission to create a place where curiosity isn\'t just encouraged—it’s celebrated. Are you someone who asks questions, seeks answers, and isn\'t afraid to go deeper?
#BeCureious
with us and see where your curiosity can take you! The Role:
/ your challenge, …in our journey We’re looking for a passionate and curious
SR GMP Compliance Specialist
to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As a
SR GMP Compliance Specialist
at
Just
Evotec Biologics , you\'ll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team. This position is responsible for the effective functioning of a cGMP manufacturing facility and providing an efficient and compliant operation and maintenance of utilities and facilities to meet the needs of the company. Note: this role does not have direct reports. What You’ll Do
Surveillance program for the critical GMP production areas and critical GMP utilities, including Water-For-Injection (WFI), Pure Steam, GMP Process Gases and the Environmental Control Program. Develop, implement and maintain the facility management program including preventative maintenance, spare parts inventory, and life-cycle requirements. Lead the investigation of facility and equipment alarms and system failures and responsible for the implementation of Corrective Actions/Preventive Actions (CAPAs) and change controls for GMP systems. Provide oversight support to the Maintenance Work Order and Calibration Programs and ensure compliance with the timely execution of the scheduled activities. Conduct and document regular inspections, maintenance and calibration of facilities and equipment. Establish and Monitor Key Performance Indicators and participates in daily work center meetings. Audit metrology activities for utilities, process equipment, and lab equipment. Comply with and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation. Provide prompt response to requests and issues from Manufacturing and Quality. Who You Are
Bachelor’s degree in Facilities Management, Facilities Engineering or related qualification. 2+ years of experience in a GMP environment with demonstrated competency in the principles and practice of cGMPs and associated regulatory considerations in a biologic manufacturing environment, including process, equipment and facility validation experience. Facilities Engineering or related qualification. 5+ years of experience in a GMP environment with demonstrated competency in the principles and practice of cGMPs and associated regulatory considerations in a biologic manufacturing environment, including process, equipment and facility validation experience. Preferred Qualifications: Experience with change control and validation related to GMP utilities and equipment. Practical knowledge of eQMS, automation (DeltaV), CMMS and BAS systems. Working knowledge of utilities and mechanical systems, and of procurement and contracts. Knowledge of health, safety and environmental regulations. Experience in maintenance and all facets of facility operation. Possess planning, organizational, problem-solving and negotiation skills. Strong focus on quality and attention to detail. Why Join Us
Growth Opportunities : We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow. Flexible Work Environment : We offer flexible work options to help you balance your professional and personal life. Site based role. Inclusive Culture : We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged. Innovative Projects : You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success. A Place for Big Ideas : We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them. Are You Still Curious?
If you’ve read this far, then chances are you’ve got a curious mind—just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you—and how it will shape the future of
Just
Evotec Biologics . Let your curiosity guide your career— #BeCurious
and explore the endless possibilities at
Just
Evotec Biologics ! The base pay range for this position at commencement of employment is expected to be $110,000 to $130,000; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits. Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
#J-18808-Ljbffr
Job Title:
Senior GMP Compliance Specialist Shifts:
Days, Monday to Friday. 8:00am till 5:00pm, 8 hours, some flexibility. About Us:
this is who we are At
Just
Evotec Biologics , we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We\'re on a mission to create a place where curiosity isn\'t just encouraged—it’s celebrated. Are you someone who asks questions, seeks answers, and isn\'t afraid to go deeper?
#BeCureious
with us and see where your curiosity can take you! The Role:
/ your challenge, …in our journey We’re looking for a passionate and curious
SR GMP Compliance Specialist
to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As a
SR GMP Compliance Specialist
at
Just
Evotec Biologics , you\'ll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team. This position is responsible for the effective functioning of a cGMP manufacturing facility and providing an efficient and compliant operation and maintenance of utilities and facilities to meet the needs of the company. Note: this role does not have direct reports. What You’ll Do
Surveillance program for the critical GMP production areas and critical GMP utilities, including Water-For-Injection (WFI), Pure Steam, GMP Process Gases and the Environmental Control Program. Develop, implement and maintain the facility management program including preventative maintenance, spare parts inventory, and life-cycle requirements. Lead the investigation of facility and equipment alarms and system failures and responsible for the implementation of Corrective Actions/Preventive Actions (CAPAs) and change controls for GMP systems. Provide oversight support to the Maintenance Work Order and Calibration Programs and ensure compliance with the timely execution of the scheduled activities. Conduct and document regular inspections, maintenance and calibration of facilities and equipment. Establish and Monitor Key Performance Indicators and participates in daily work center meetings. Audit metrology activities for utilities, process equipment, and lab equipment. Comply with and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation. Provide prompt response to requests and issues from Manufacturing and Quality. Who You Are
Bachelor’s degree in Facilities Management, Facilities Engineering or related qualification. 2+ years of experience in a GMP environment with demonstrated competency in the principles and practice of cGMPs and associated regulatory considerations in a biologic manufacturing environment, including process, equipment and facility validation experience. Facilities Engineering or related qualification. 5+ years of experience in a GMP environment with demonstrated competency in the principles and practice of cGMPs and associated regulatory considerations in a biologic manufacturing environment, including process, equipment and facility validation experience. Preferred Qualifications: Experience with change control and validation related to GMP utilities and equipment. Practical knowledge of eQMS, automation (DeltaV), CMMS and BAS systems. Working knowledge of utilities and mechanical systems, and of procurement and contracts. Knowledge of health, safety and environmental regulations. Experience in maintenance and all facets of facility operation. Possess planning, organizational, problem-solving and negotiation skills. Strong focus on quality and attention to detail. Why Join Us
Growth Opportunities : We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow. Flexible Work Environment : We offer flexible work options to help you balance your professional and personal life. Site based role. Inclusive Culture : We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged. Innovative Projects : You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success. A Place for Big Ideas : We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them. Are You Still Curious?
If you’ve read this far, then chances are you’ve got a curious mind—just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you—and how it will shape the future of
Just
Evotec Biologics . Let your curiosity guide your career— #BeCurious
and explore the endless possibilities at
Just
Evotec Biologics ! The base pay range for this position at commencement of employment is expected to be $110,000 to $130,000; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits. Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
#J-18808-Ljbffr