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Validation Engineer

Precision for Medicine

Precision for Medicine

Indianapolis, IN, USA
Posted on Sunday, April 14, 2024

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 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:

  • Bachelor’s degree in Life Science, Engineering, or related discipline and/or comparable military experience
  • 0-1 years of consulting and/or project engineer experience
  • 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 up to 100%
  • 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
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$61,000$65,000 USD

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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, LLC

If 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.