Cleaning Operations Lead (GMP Manufacturing) at Poseida Therapeutics Inc

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Jan, 26

Salary

71.88

Posted On

17 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Leadership, Communication, Interpersonal Skills, Documentation, Report-Writing, Problem Solving, Detail Oriented, Team Player, GMP, ISO Standards, Cleanroom Protocols, Training, Inventory Management, Continuous Improvement, Cleaning Techniques, Health and Safety Regulations

Industry

Biotechnology Research

Description

Description ** Please note that position hours: Mon-Fri 10:00am to 6:30pm, with some overtime, weekends and holiday work required. Your Impact Join our mission to cure cancer. We are seeking a driven and technically skilled Validation Engineer to become a vital part of our team. In our fast-paced, cGMP aseptic manufacturing facility, you will be a critical force in ensuring the equipment and systems that produce our life-saving therapies meet the highest standards of quality and compliance. If you are passionate about applying your validation expertise to make a tangible impact on the lives of patients, we want to hear from you. Position Summary The Cleaning Operations Lead is part of the Poseida internal manufacturing team in support of Poseida’s clinical production of cell therapies. This position will oversee and verify the cleaning processes for our ISO Class 7 and ISO Class 8 cleanroom areas. This role is critical in ensuring we maintain the highest standards of cleanliness and compliance with regulatory guidelines. The ideal candidate will have strong leadership skills, a deep understanding of Good Manufacturing Practices (GMP), and experience in a cleanroom or controlled environment. Responsibilities These may include but are not limited to: Supervise a team of contract cleaning technicians, ensuring all tasks are completed according to established Standard Operating Procedures (SOPs) and schedules. Conduct frequent inspections and audits of the ISO 7 and ISO 8 areas to verify cleaning effectiveness. Liaison with the Contract Cleaning service management to determine cleaning schedules, keep records of contract cleaning personnel, send any required emails or other communication and any administrative activities associated with working with a contract cleaning company. Lead weekly or bi-weekly meetings with the contract cleaning management and Poseida manufacturing management to give updates on cleaning, any deviations that have occurred and other events. Train new and existing staff on proper cleanroom cleaning techniques, gowning procedures, and the correct use of cleaning agents and equipment. Foster a culture of compliance and continuous improvement within the team. Maintain accurate and up-to-date records of all cleaning activities, including logbooks, checklists, and incident reports. Document any non-conformances and escalate issues to management as needed. Ensure all cleaning activities adhere to ISO standards, internal quality control protocols and SOPs, and health and safety regulations. Monitor and manage the inventory of cleaning supplies and personal protective equipment (PPE) including gowning and collaboration with Vestis. Identify and troubleshoot issues related to cleaning effectiveness or equipment functionality. Assist in implementing corrective and preventive actions (CAPA) to address recurring problems. Assist in any deviations related to cleaning activities. Maintain and update any SOPs related to the cleaning of the manufacturing facility Requirements Requirements, Knowledge, Skills and Abilities High school diploma or equivalent required; an associate's or bachelor's degree in a related scientific or technical field is a plus. Minimum of 1-2 years of experience in a lead role, with at least 2-3 years of direct experience in a controlled environment, cleanroom, or cGMP facility. Strong knowledge of ISO standards and cleanroom protocols. Excellent leadership, communication, and interpersonal skills. Proficiency in documentation and report-writing Excellent skills in Microsoft Word, Excel, and Power Point Self-motivated, positive, and willing to accept temporary responsibilities outside of initial job description Willingness to think outside of the box as well as comfortable in a fast-paced and constantly evolving environment Will require work off shift hours, weekends, and some holiday work Ability to follow verbal and written instructions Problem Solving skills Detail oriented Team player Work is generally performed in a GMP manufacturing facility Able to lift 40 pounds and stand for hours at a time The position requires a combination of standing or sitting in a cleanroom manufacturing environment as well as walking around the facility Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body Position Title Pay Rate: $38.70/hour to $71.88/hour The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc. Who We Are and What We Do Poseida Therapeutics was acquired by Roche in early 2025 and is now part of the Roche Group. Poseida is a clinical-stage biopharmaceutical company advancing differentiated allogeneic cell therapies and genetic medicines with the capacity to cure. The Company's approach is based on its proprietary genetic editing platforms, including its non-viral DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System, Booster Molecule and nanoparticle gene delivery technologies, as well as in-house GMP cell therapy manufacturing. Our people are as important as our cutting-edge technology. That’s why we invest in offering excellent career development opportunities to our employees, as well as highly competitive compensation and comprehensive benefits. We are committed to giving employees the resources they need to thrive, personally and professionally. Within the Roche organization, a healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Recruitment Fraud Alert Alert: Beware of Employment Scams Poseida Therapeutics, Inc. has received reports of employment-related scams. These scams have appeared in forms of false job advertisements and/or unsolicited contacts via communication/chat platforms, phone, email or text from individual(s) claiming to be or represent Poseida’s Human Resources team. Be advised that Poseida Therapeutics does not extend unsolicited employment offers. Furthermore, Poseida Therapeutics does not request payment information or charge prospective employees with any fees during the recruitment process. If you would like to pursue employment opportunities with Poseida Therapeutics, Inc., please visit our official careers website https://poseida.com/careers-culture/ or official Poseida Therapeutics LinkedIn page. Job postings that do not link directly to our careers website or official Poseida LinkedIn page are not legitimate and might be fraudulent. You may report fraudulent job advertisements or contacts via our Contact Us page at https://poseida.com/contact-us/ and select the subject “Careers.” If you have been defrauded or suspect identity theft as a result of an employment scam, please contact your local law enforcement agency for guidance.

Responsibilities

The Cleaning Operations Lead supervises a team of cleaning technicians and ensures compliance with cleaning standards in ISO Class 7 and ISO Class 8 cleanroom areas. This role includes conducting inspections, training staff, and maintaining records of cleaning activities.