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Senior Project Engineer

Project FarmaBethesda, Maryland, United StatesOnsite
This job is no longer open

Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry.  We provide biomanufacturing strategy and execution to start up and established gene and cell therapy, pharmaceutical, and biotechnology companies.  We are an industry leader in providing project management, validation, engineering, quality/compliance, and consulting services to support our partners in finding ground-breaking treatments and solutions.  We are committed to advancing manufacturing to achieve operational excellence and accelerate speed to market for next-generation medicines.  Our culture of philanthropy, teamwork, training and development and commitment is the foundation to our teams’ and partners’ long-term success.  
Project Farma is a wholly owned subsidiary of Precision Medicine Group, LLC, a leading global life sciences company with over 2,000 employees. 

Position Summary:                                              


The Senior Project Engineer will work collaboratively with partners, vendors, contractors, and other Project Farma (PF) Team Members to support projects related to biomanufacturing across the entire lifecycle to further our mission of accelerating market access for next-generation medicines.  The Project Engineer is responsible for delivering high quality work, building valuable and long-term relationships with our partners, and continually strengthening their technical and industry knowledge in a growing and evolving field.  The Project Engineer will maintain a strong focus on PF’s Patient Focused mission and represent the organization in alignment with our core values.

Essential functions of the job include but are not limited to:


Excellence in Technical Delivery

  • Coordinate with cross-functional departments including but not limited to Validation, Manufacturing, Quality, Supply Chain, and Engineering to:
  • Provide hands-on support navigating the life cycle of cutting-edge equipment
  • Author technical documents such as SOPs, protocols, summary reports, etc.
  • Support the overall development of pharmaceutical biomanufacturing programs
  • Execute system and process validation protocols
  • Continually develop technical aptitude of PF’s core capabilities including but not limited to:
  • Project Management
  • Cell and Gene Therapy
  • Capital Projects
  • Facility Builds
  • Tech Transfers
  • Validation Life Cycle
  • Commissioning and Qualification
  • Quality, Regulatory, and Compliance
  • Engineering Automation and Serialization
  • Reliability, Maintenance, and Asset Management

Project Support

  • Meet key project timelines and proactively communicate project status
  • Build meaningful relationships with our partners
  • Support site dashboards and proposal generation
  • Contribute to and enhance our patient focused culture

Qualifications:


Minimum Required:

  • Bachelor’s degree in Life Science, Engineering, or related discipline and/or comparable military experience
  • 1-4 years of consulting and/or project engineer experience

Other Required:

  • Full COVID-19 vaccination is required prior to the employee's start date with exceptions for medical and religious accommodations when reasonable
  • Willingness to travel and/or relocate

Preferred:

  • Great soft skills, excellent verbal and written communication
  • Effective time management, prioritization, and follow through
  • Value committed with a high level of integrity
  • Dedicated work ethic
  • Demonstrate strong personal attributes that include teamwork, professionalism, and the ability to see the “big picture”

In return for your skills, knowledge, and passion, Project Farma offers a wide range of benefits including:


  • Competitive salary based on experience 
  • Aggressive bonus structure  
  • Medical, Dental, and Vision insurance effective your first day of employment  
  • 401k Plan with company match 
  • Paid Time Off and Company Paid Holidays
  • Company Paid Maternity and Parental Leave
  • Continuing Education Assistance  

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

This job is no longer open

Life at Project Farma

Project Farma is a consulting firm that partners with cutting-edge healthcare companies across the complete supply chain (pharmaceutical, biotech, gene therapy, medical device manufacturers, distribution centers, hospitals, wholesalers). We partner with our clients to safely deliver ground-breaking treatments to patients. One of our core values is giving back. Volunteering at hospitals, supporting healthcare-related fundraisers and partnering with several nonprofit organizations is an integral part of our culture. In doing so, not only do we raise awareness of many life-threatening diseases, but also bring our team and our client's team closer to the actual patients that will be impacted by our work. CORE COMPETENCIES: Validation Farma - a Project Farma Division - Validation Program Development -- Service the Gamut of the Validation Lifecycle -- Validation Lead Planning and Strategy Development -- Computer, IT, and Equipment Validation -- Cleaning and Steaming Validation -- Process Performance Qualification Validation (24/7 PPQ support) -- Laboratory & COTS Validation Quality Audits & Assurance -- Computer and IT Audits -- CMO/TPO Auditing and Management -- Quality Assurance FTE Backfill Capital Project Organization: GMP Compliant Turnkey Solution -- Project Management, Validation Technical Lead, Engineering Technical Lead, Automation Technical Lead, Construction Management, Quality Assurance Lead -- Business Case through Implementation -- Vendor Management Engineering, Software and Automation Organization -- System Owner, Process Engineers, Automation, Software Backfill Roles -- Asset Management & Change Control Support, Policies and Procedures -- Conceptual through Detailed Design and Implementation Serialization - Track & Trace -- Global Serialization Regulations - DSCSA, ANVISA, SFDA, etc. -- Serialization and TT Audits, CMO & DC Vendor Management -- Line upgrades/controls integrated to ERP/IT Cloud HOW TO REACH US: Project Farma Corporate Office 810 W. Randolph St, 2nd Floor Chicago, IL 60607 partnerships@projectfarma.com 302.455.2488
Thrive Here & What We Value1. Patient Focused and People First delivery team2. Commitment to advancing manufacturing for operational excellence and accelerating speed to market for next-generation medicines3. Culture of philanthropy, teamwork, training and development, commitment to the patient as foundation for long-term success4. Wholly owned subsidiary of Precision Medicine Group, LLC5. Dynamic team composed of vibrant professionals passionate about delivering high quality work globally6. Constantly pushing boundaries and redefining standards of excellence7. Covid Vaccine requirement with exceptions for medical/religious accommodations8. Full time on-site client presence9. Willingness to travel up to 100% or as required for project and business needs10. Patient Focused philosophy
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