Manager, Gxp Validation, Calibration and Engineering - San Diego, United States - Artiva Biotherapeutics

Artiva Biotherapeutics

Verified Company

San Diego, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

About Artiva

Job Summary

The Manager, GxP Validation, Calibration, and Engineering, is responsible for developing the Validation and Calibration functions at Artiva, which include managing consultants and contractors to support operation activities such as facility buildouts and commissioning, qualification and validation of equipment and systems to support GxP operations.

The incumbent is also responsible for developing and managing equipment history files for GxP equipment, which encompasses initial qualification, calibration, maintenance, and re-qualification throughout the equipment and systems lifecycle.

Responsibilities

Lead the daytoday activities of the calibration and validation program by developing relevant functional procedures, program structure, deliverables, dashboards, monitoring, and reporting.
Lead the validation program by developing, reviewing, and approving validation lifecycle documents for facility commissioning as specified in the validation master plan and internal SOPs (e.g. Validation Plans, Protocols and Reports, URS, Technical Specifications)
Source and implement an electronic CAL/PM program for management of GxP equipment. May require sourcing of regulated software.
Oversee outsourced calibration and certification activities.
Coordinate activities related to the GMP space.
Initiates deviations, conducts investigations and impact assessments, proposes action plans, change controls and to address GxP Validation, Calibration and Engineering
Develop risk assessments, FMEA to support commercialization.
CMC support of regulatory filings.
Ensure adherence to all relevant regulatory requirements, Validation Master Plan and internal procedural requirements.
Maintain a safe work environment; work in a safe manner, following all safety SOP's and wear Personal Protective Equipment as required.
Act as the point person for the facilities & equipment technicians while working closely with management to ensure strategic planning, implementation of plans, resolving problems, while maintaining production quality.
Assist with bids for GMP facility work to be completed. Assist with the negotiation of vendor contracts. Oversee and schedule all vendor mechanical equipment systems work and contractor services.
Manage external service providers, ensuring that deliverables are met in a timely manner and within budget. Monitors and maintains the contractor's performance and works closely with outside vendors to ensure work is completed according to specifications.
Ensures clean rooms and general facility are maintained in optimum condition and in compliance with GMP requirements (e.g. owning the calibration program)
Routinely survey and evaluate necessary maintenance to the facility and facilitate maintenance, testing, troubleshooting and repair on systems while maintaining proper records.
Observe and trend facility issues for continuity and improvement.
Provide internal consulting support to reduce variability and improve efficiency as needed.
Maintain accurate records keeping equipment and systems cGMP compliant at all times. Ensures maintenance work orders are being completed on time while adhering to operational standards. Maintain and organize spare parts and consumables.
In partnership with management, ensure compliance with all applicable regulatory agencies, including FDA, CA FDB, OSHA, DOH, EPA, Fire Department, city audits, Health Department, etc.
Oversee construction and equipment installation, and preventative maintenance, related to the GMP areas.
Assist in project completion and may provide recommendations and solutions to technical problems and facility issues.

Qualifications

Bachelor's degree or higher in Engineering, Life Sciences, or related field.
Extensive experience (typically 8+ years) in calibration and validation within a GMPregulated industry, with progressive leadership responsibilities.
Indepth knowledge of GMP regulations and guidelines (e.g. FDA 21 CFR Part 210/211, EU GMP Annex 15).
Strong technical experience in calibration principles, validation methodologies, and riskbased approaches.
Strong leadership and crossfunctional collaboration to drive change.
Excellent communication, interpersonal, and problemsolving skills.
Detailoriented with a focus on quality, compliance, and continuous improvement.
Proven ability to meet tight timelines, multitask, and prioritize workloads.

Why you should apply:

We have a fantastic team and philosophy We are passionate - we deeply care about our team, our science, and improving the lives of cancer patients.

We are tenacious - laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients.

We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive - committed to the diversity of our tea