Project/Validation Engineer at Project Farma

San Francisco, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

NoVisa

Life Sciences, PharmaceuticalsIndustries

Requirements

Bachelor’s Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in CQV engineering, cGMP facility start-up, project management and/or comparable military experience)
Authorized to work in the United States on a full-time basis (no sponsorship for work visas)
Full-time on-site client presence
Willingness to travel as required to support project and business needs
Valid driver's license
Currently or will live in the area where the job is posted
Thrive in a fast-paced environment
Detail-oriented with natural leadership qualities
Philanthropic drive embodying Patient Focused and People First Mission

Responsibilities

Provide hands-on support and troubleshooting for clients navigating the engineering life cycle of cutting-edge equipment and manufacturing processes
Create alignment with cross-functional client departments including Validation, Manufacturing, Quality, Supply Chain, and Engineering
Proactively identify and escalate roadblocks
Utilize critical thinking and problem-solving skills to identify creative solutions to problems and roadblocks
Perform due diligence on system and subject domains to generate high-quality project deliverables
Author technical documents such as SOPs, requirements specifications, testing protocols, summary reports, etc
Execute system and process validation protocols using GxP best practices

Skills

Key technologies and capabilities for this role

ValidationManufacturing ProcessesTroubleshootingProject EngineeringQuality AssuranceSupply Chain ManagementCross-Functional CollaborationProblem SolvingCritical Thinking

Questions & Answers

Common questions about this position

Is this position remote or on-site?

This is a full-time on-site position requiring client presence.

What travel is required for this role?

The position may require significant travel to support project and business needs, and candidates must love to travel.

What education or experience is required for this Project Engineer role?

A Bachelor’s Degree in Life Science, Engineering, or related discipline is required, or a combination of equivalent work experience in CQV engineering, cGMP facility start-up, project management and/or comparable military experience.

What are the key skills and qualities needed for this position?

Candidates must thrive in a fast-paced environment, be detail-oriented with natural leadership qualities, and possess critical thinking and problem-solving skills.

What is the company culture like at Project Farma?

The company has a dynamic team of vibrant professionals passionate about high-quality work, innovation, and a Patient Focused and People First Mission, with opportunities for professional development and philanthropy.

Project Farma

Biomanufacturing services for cell and gene therapy

About Project Farma

Project Farma specializes in biomanufacturing, focusing on cell and gene therapy. The company develops and implements strategies for advanced therapy facilities, helping clients create treatments that modify genes to address diseases. Their services encompass the entire lifecycle of biomanufacturing projects, including facility construction, validation, quality assurance, regulatory compliance, and automation. Project Farma distinguishes itself by offering comprehensive, turnkey solutions that ensure facilities meet Good Manufacturing Practices (GMP), which is essential for producing safe therapies. Their goal is to enhance patient outcomes through effective project execution and they also emphasize philanthropy and professional development within their team.

Chicago, IllinoisHeadquarters

2016Year Founded

ACQUISITIONCompany Stage

Consulting, Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Company Match

Paid Vacation

Company Paid Maternity and Parental Leave

Continuing Education Assistance

Risks

Emerging biomanufacturing consulting firms increase market competition.

Rapid technological advancements may require significant investment to stay competitive.

Economic downturns could reduce demand from biotech startups.

Differentiation

Project Farma specializes in cell and gene therapy facility builds and compliance.

They offer turnkey solutions, managing projects from planning to execution.

Their focus on philanthropy and professional development sets them apart.

Upsides

Rising demand for cell and gene therapies boosts need for specialized facilities.

Advancements in automation enhance efficiency and cost-effectiveness of services.

Complex regulatory requirements increase demand for Project Farma's consulting expertise.

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