- Leads daily activities of Maintenance and Instrumentation Technicians in the maintenance, repair, calibration of equipment and/or mechanical, electrical systems in respective area of responsibility, ensuring that Standard Operating Procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements are followed.
- Ensure all single-use, commercial manufacturing equipment is operational and ready for viral vector production
- Supervises Maintenance and Instrumentation Technicians, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
- Authors SOP documents.
- Works with MRO and Facility Specialist to procure spare parts, labor, special tools, contracts, and equipment availability for work execution.
- Manages and implements investigation, assessment, and delivery of ongoing improvements to facilities, utilities, installations, and equipment.
- Serves as a mentor to Jr. technicians
- Author and assess quality records such as deviations and CAPAs
- Ensures that Standard Operating Procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements are followed
- Provides refresher training to departmental size groups
- Will participate in regulatory audits to include internal, vendors or contract manufacturers.
- Estimates jobs showing sequence of steps, the number of mechanics and required man-hours for each step
- Ensures the safety needs are given a top priority in work planning and scheduling.
- Receives all work orders from the requesting departments of the areas to which he/she is assigned, except for emergency work that is requested of the appropriate maintenance supervisor for immediate attention
- These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
- Additional duties as assigned.
- In-depth understanding and application of cleanroom design, facilities, and utilities such as WFI, compressed gases, electrical infrastructure,
- In-depth knowledge of current Good Manufacturing Practices (cGMPs).
- Extensive working knowledge of facilities, utilities, and commercial manufacturing
- Extensive knowledge of industry & Good Engineering practices.
- Excellent verbal, written, and interpersonal communication skills are required.
- Demonstrated investigation and report writing skills.
- Proficient in Microsoft Office applications.
- Master's degree in mechanical, electrical, or chemical engineering with 3+ years of experience in facilities, utilities engineering in the biotech/pharma industry
- Bachelor's degree in mechanical, electrical, or chemical engineering with 5+ years of experience in facilities, utilities engineering in the biotech/pharma industry Or
- High School diploma with 9+ years of experience in facilities, utilities engineering in the biotech/ pharma industry
- 8+ years of previous experience in biotech or pharmaceuticals industry working in a cGMP environment. Experience with commercial manufacturing is highly preferred
- Has previous experience in facilities, utilities, or process engineering in highly regulated manufacturing environments, ideally commercial, biopharma cGMP facilities
- Experience providing maintenance support for Single Use Systems/Technologies/Equipment
- Regulatory Agency Experience is greatly preferred
- Excellent verbal and written communication skills
- Ability to work cross-functionally in a matrix environment
- Excellent collaboration skills and the ability to work well as part of a team
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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Maintenance Team Lead - Oceanside, United States - Gilead Sciences, Inc.
Description
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site $) to apply for this job.
At Kite, we empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
Job Description
Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a line between that purpose and our day-to-day work. Join us in our mission
We are seeking a highly effective Maintenance Team Lead to be responsible for supporting the design, engineering, and implementation of capital projects at Oceanside viral vector manufacturing site as well as the delivery of ongoing improvements to facilities, utilities, installations, and equipment.
Responsibilities (include but are not limited to):
Knowledge and Skills
Basic Qualifications:
Preferred Qualifications:
The salary range for this position is: $97, $126, Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow @KitePharma on Twitter at .
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT )
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION )
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site $) to apply for this job.
Change The World With Us
Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.
While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.