Senior Factory Service Engineer at Cellares

South San Francisco, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Cell Therapy, BiotechnologyIndustries

Requirements

Bachelor’s degree or equivalent in engineering or a related field
5+ years’ experience in a GMP manufacturing environment, preferably in cell therapy or biopharmaceuticals
Strong understanding of GMP regulations and quality standards
Experience as a technical/service lead on a multi-subsystem installation/qualification
Proficient in troubleshooting and repairing complex manufacturing equipment
Ability to read and understand technical documents and engineering drawings
Excellent organizational and documentation skills
Ability to work collaboratively in a team-oriented environment
Effective communication skills to interact with diverse stakeholders
Must be able to work a full-time, 40-hour work week, including swing shifts, weekends, and holidays, as required to support business needs
Attendance at the plant site is considered an essential function
Detail-oriented with a commitment to maintaining high-quality standards
Must be able to lift and carry up to 50 lbs
Excellent verbal, written, organizational, presentation, and interpersonal skills
Self-Awareness, integrity, authenticity, and a growth mindset
Participate in an after-hours on-call rotation to support GMP facility operations is required and managed through PagerDuty
Experience drafting and maintaining Standard Operating Procedures (SOPs) and Work Instructions (WIs)

Responsibilities

Perform installations, routine maintenance, and troubleshooting of Cellares and other process equipment within a Good Manufacturing Practice (GMP) environment in a cell therapy manufacturing facility
Collaborate with cross-functional teams to ensure compliance with GMP standards and regulations
Perform equipment calibrations and support validation testing to meet quality and regulatory requirements
Respond promptly to equipment failures and implement corrective actions to minimize downtime
Execute preventive maintenance activities to ensure optimal functionality of manufacturing equipment
Maintain accurate documentation of all maintenance activities and equipment logs in a Computerized Maintenance Management System (CMMS)
Manage parts ordering and coordinate with equipment and area owners to schedule maintenance activities
Maintain tools and test equipment, and ensure they are properly calibrated and in good, safe working condition
Collaborate with manufacturing and quality control teams to address technical issues and optimize processes
Support Quality Change Controls and CAPA investigations
Stay updated on industry trends and advancements to contribute to continuous improvement initiatives
Participate in training programs to enhance technical skills and knowledge

Skills

Key technologies and capabilities for this role

GMPCMMSEquipment CalibrationTroubleshootingPreventive MaintenanceEquipment RepairValidation TestingCAPAQuality Change Controls

Questions & Answers

Common questions about this position

What is the salary for this Senior Factory Service Engineer position?

This information is not specified in the job description.

Is this role remote or onsite, and where is it located?

This is a hands-on position local to the South San Francisco, CA facility, primarily based there with up to 20% travel to Bridgewater, New Jersey, and other Cellares locations.

What are the key required skills and experience for this role?

Candidates need a Bachelor’s degree in engineering or related field, 5+ years in GMP manufacturing (preferably cell therapy or biopharma), strong GMP knowledge, troubleshooting complex equipment, and excellent organizational, documentation, and communication skills.

What is the work environment like at Cellares?

It's a fast-paced, mission-driven environment where candidates tackle a wide range of challenges as the company expands, involving collaboration with cross-functional teams in a GMP cell therapy manufacturing facility.

What makes a strong candidate for this Service Engineer role?

Strong candidates have 5+ years in GMP manufacturing, experience as a technical/service lead on multi-subsystem installations, proficiency in troubleshooting equipment, and the ability to work collaboratively with excellent documentation and communication skills.

Cellares

Develops and manufactures cell therapies efficiently

About Cellares

Cellares develops and manufactures cell therapies in the biotechnology sector, operating as an Integrated Development and Manufacturing Organization (IDMO). Its proprietary "Smart Factory" technology features an automated single-use cartridge system, which increases productivity and reduces costs and process failures compared to traditional methods. The company serves a range of clients, including pharmaceutical companies, and aims to provide efficient and cost-effective manufacturing services for cell therapies. Cellares stands out by combining development and manufacturing processes under one roof, making it a competitive option in the industry.

South San Francisco, CaliforniaHeadquarters

2019Year Founded

$345.3MTotal Funding

SERIES_CCompany Stage

Industrial & Manufacturing, BiotechnologyIndustries

201-500Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Company Match

Stock Options

Risks

Emerging biotech startups threaten Cellares' market share with similar solutions.

Potential regulatory delays could impact scaling of new automated systems like Cell Q.

Supply chain vulnerabilities may disrupt production timelines for Cell Shuttle and Cell Q.

Differentiation

Cellares' Cell Shuttle offers 10x scalability over manual cell therapy manufacturing.

The Smart Factory technology integrates development and manufacturing, unlike traditional CDMOs.

Cell Q automates QC processes, addressing bottlenecks in cell therapy quality control.

Upsides

Partnership with Sony enhances precision in cell therapy manufacturing processes.

Strategic partnership with Bristol Myers Squibb provides financial boost and validation.

Ossama Eissa's appointment as COO accelerates global expansion and operational capabilities.

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