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Facilities Planning Manager

Orca Bio

Operations

Sacramento, CA, USA

Posted on Aug 10, 2024

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More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

SUMMARY: The Facilities Planning Manager is responsible for asset management across multiple production sites producing clinical and commercial drug products. This role involves utilization of a Computerized Maintenance Management System (CMMS) to manage asset data, asset labelling, asset status, preventative and corrective maintenance, and calibration & certification activities to ensure compliant and reliable asset operations to support production requirements to meet customer needs.

The position may split time between our clinical manufacturing facility (3400 Business Drive, Sacramento, CA) and our commercial manufacturing facility (7910 Metro Air Parkway, Sacramento, CA).

Duties

Develop, implement, revise and execute Standard Operating Procedures (SOPs) and Work Instructions (WIs) for GMP Facility and asset management programs, including a GMP Computerized Maintenance Management System (CMMS), and facility and equipment operation, maintenance and calibration programs
Onboarding new assets and maintaining current assets in the CMMS, including asset identification and status, labelling, and assigning required maintenance, calibration and certification plans
Planning, scheduling and coordinating onsite and offsite maintenance and calibration activities to be completed by service providers or company personnel
Review, approval and retention of service provider documentation
Completion and closeout of tasks in the CMMS
Ensure that the facility and assets are maintained, calibrated and certified to applicable GMP standards
Execution of facility preventative and corrective maintenance tasks, and small projects and continuous improvements
Manage spare parts program to ensure strategies are developed and required inventory is in place
Tracks and reports metrics on asset maintenance and identifies risk, needs and opportunities

Required Experience

5+ years of relevant experience, ideally in pharmaceuticals/biotech, including:
Using a GMP CMMS (Computerized Maintenance Management System) for asset management.
Implementing a CMMS, preferably in a GMP environment.
Developing and implementing SOPs and WIs for GMP facility and asset management programs.
Demonstrated knowledge of facility and asset maintenance and calibration programs.
Planning, scheduling and coordinating GMP facility and asset maintenance and calibration activities.
Effective communication and coordination skills to consult with internal teams and external service providers.
Proactive approach to identifying and implementing improvements in asset management systems and work processes.
Familiarity with industry best practices and a commitment to staying updated on emerging trends in facilities and asset management.

Desired Attributes

Ability to effectively multitask, handle and prioritize multiple responsibilities simultaneously
Strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
Strong interpersonal skills and ability to communicate effectively
Problem-solving and critical thinking skills to support making decisions in a timely manner
Ability to gown and work in clean room areas from time to time
Ability to work in a collaborative manner, independently and as part of a team
Ability to work in a fast-paced start-up environment while following documented procedures and instructions
Strong problem-solving skills with desire to improve upon established processes
Ability to work for long periods of time at a computer
Occasional need to ascend/descend stairs within the workspace; job requires sitting, standing/walking

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

To learn more: https://orcabio.com/join-our-team/

**all official communication will be from @orcabio.com; please beware of scams**

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

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