Location: Menlo Park, California
Reporting to: Director, Facilities
This an exciting opportunity for a suitable candidate to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.
Orchard Therapeutics, Ltd. (OTL) is looking for an individual to be responsible for the physical and administrative tasks involved in the programming, scheduling, tracking, review and closeout of PM’s, calibrations and qualifications including other duties as assigned.
- Daily review of the equipment maintenance, calibration and qualification calendar for scheduled equipment maintenance, calibrations and qualifications and generation and distribution of the monthly PM & qualification due lists and calibration recall list.
- Daily review and follow-up of the PM & qualification due lists, calibration recall list and the work request system for PM’s, qualifications, calibrations due and work request acknowledgement, approval, generation, closeout and follow up as needed.
- Close out and filing of completed PM work orders, work requests, completed calibrations, qualifications and updating of the equipment, calibration and qualification program calendar.
- Assist equipment end users with the creation of and creation of facility dept. new equipment enrollment forms, including calibration test points and tolerances, equipment history files, PM, calibration and qualification job plans and schedules, review & update equipment, calibration and qualification scheduling database and other relevant systems and documentation.
- Coordinate, schedule and oversee all activities between departments and outside vendors or contractors related to preventative maintenance, calibration and/or qualification services and inspections.
- Perform facility inventory management and other inventory & purchasing duties as needed.
- Assist with the administration, maintenance and implementation of EH&S policies, procedures, programs and reports.
- Perform departmental administrative duties such as:
- Generate purchasing requests for non-controlled and controlled materials, gases, equipment, miscellaneous supplies, replacement spare parts and supplies.
- Generate annual vendor service contract related letters and blanket purchase order request and issuance.
- Create, maintain and distribute calibration, maintenance and qualification metrics, departmental metrics, equipment usage metrics, weekly department meeting materials and reports.
- Generate various reports and copies as requested/required by internal and external requirements, i.e. audits, OOT reporting, OOT follow-ups, etc.
- Interface, schedule, escort and supervise related service vendors as required.
- Catalog, update, and redline blue prints, drawings, control schemes and layouts, equipment manuals, technical data sheets, instrument/equipment capabilities and process related data/information in conjunction with facility technicians and equipment end users.
- Provide back-up support to materials management as needed, including various packaging and process related activities.
- Administrator of facility security/card key system, securing, issuing and maintaining of the security/card key system. Review of security system daily reports for issues and trending
- Respond to after-hours call-ins for emergencies, equipment related issues when providing facility backup
- Will also schedule and assist with furniture, office equipment and laboratory equipment moves
- Will be required to work in laboratory and Clean Room Environments
- Provides support in general facility operations
- Other activities as assigned
The ideal candidate must possess the following skills:
- Previous experience in a facility coordinator role in the biotech, medical device or pharmaceutical industry
- Calibration, Preventative Maintenance and Validation System Administration
- Schedule review, notification, equipment, end user and service provider scheduling
- Technical review and approval of documentation, certifications, work orders and work requests
- Asset Management Database maintenance and administration
- Ability to participate and succeed in multi-level, multi-disciplinary cross functional teams
- Ability to regularly lift a minimum of 50 lbs
Education & skills
- At least three years relevant experience in a fast paced GMP manufacturing environment preferred
- High School Diploma required
- BS degree preferred
- Strong computer skills with Microsoft Office Suite of programs required
- Must be organized, customer focused, and have the ability to multitask
- Excellent verbal and written skills required
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
Notice to RECRUITERS: All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.