Supervisor, Manufacturing GMP Cleaning and Sanitization
Supervisor, Manufacturing GMP Cleaning and Sanitization
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$ 94000 - 117500
1 Vacancy
Job Description
Our purpose is to bring hope to life by enabling lifechanging therapies for patients around the globe creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.
JOB SUMMARY
The Supervisor Manufacturing GMP Cleaning and Sanitization is responsible for supervising and ensuring the thorough and compliant execution of cleaning and sanitization activities in a regulated GMP environment. The role oversees the team responsible for maintaining cleanliness and aseptic conditions across production areas ensuring that all activities adhere to Standard Operating Procedures (SOPs) and regulatory requirements.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES
Supervise and coordinate routine and scheduled cleaning and sanitization of cleanrooms production areas and equipment ensuring strict adherence to GMP guidelines and SOPs.
Review and verify documentation related to cleaning and sanitization and operations activities for completeness accuracy and compliance with regulatory and company standards.
Conduct and oversee inspections of sanitized areas to ensure cleanliness and ongoing GMP compliance.
Manage inventory and procurement of facility supplies (e.g. gowns disinfectants wipes) ensuring uninterrupted operation of GMP areas and minimizing downtime.
Partner with Quality Assurance to maintain audit readiness and support the continuous improvement of cleaning protocols and compliance procedures.
Lead preparation efforts for internal and external audits and inspections ensuring all documentation and processes within compliance.
Ensure team adherence to safety protocols including proper chemical handling waste disposal and equipment use and enforce documentation and compliance tracking via internal systems.
Oversee the safe transport and traceability of parts between departments ensuring procedures align with GMP/GDP standards.
Monitor and supervise sanitization of parts including washing and sterilization processes ensuring consistency with cleanliness and safety standards.
Ensure proper operation of autoclave equipment providing training and oversight to staff and confirming sterilization practices meet GMP requirements.
Oversee the assembly and kitting of parts verifying accuracy timeliness and proper delivery to production areas.
Review and approve documentation for part transport cleaning autoclaving and delivery activities ensuring full compliance with regulatory requirements.
Foster crossfunctional collaboration acting as a liaison between production quality and facilities to ensure seamless daily operations and resolution of issues.
Monitor supply levels and equipment performance coordinating timely replenishment and maintenance to support efficient and uninterrupted operations.
SKILLS
Lead mentor and manage a team of GMP cleaners and sanitizers on night shift.
Ensure all team members are trained and compliant with SOPs and GMP regulations.
Schedule and oversee daily cleaning tasks and ensure efficient workflow management.
Act as the primary point of contact for the team handling escalations and issues as they arise.
QUALIFICATIONS
Required:
BS/BA degree with 5 years of industry experience. Equivalent education and experience may substitute for stated requirements.
Physical Requirements:
Must be able to perform aseptic gowning and work in a clean room environment.
Must be able to lift/carry up to 40 pounds and complete required paperwork.
Must be able to sit and stand for extended periods.
Must be available to work twelvehour shift
SCHEDULES
Front Half Days Sunday to Wednesday 6am to 4:30pm
Front Half Swing Sunday to Wednesday 3pm to 1:30am
Back Half Days Wednesday to Saturday 6am to 4:30pm
Back Half Swing Wednesday to Saturday 3pm to 1:30am
COMPENSATION
$94000$117500
Our culture at AGC Biologics is defined by the six core values: Knowledge Trust Quality Ingenuity Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased therapeutic proteins plasmid DNA (pDNA) messenger RNA (mRNA) viral vectors and genetically engineered cells. Our global network spans the U.S. Europe and Asia with cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.Want to keep posted about our growth and learn more about our company Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age ancestry color family or medical care leave gender identity or expression genetic information marital status medical condition national origin physical or mental disability political affiliation protected veteran status race religion sexual orientation or any other characteristic protected by applicable laws regulations and ordinances.
Required Experience:
Director
Employment Type
Full-Time
