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Validation Engineer

Project FarmaIndianapolis, Indiana, United StatesOnsite
This job is no longer open

Why Precision for Medicine?


Welcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science industry, we are constantly pushing the boundaries of what is possible and redefining the standards of excellence. Our dynamic team is composed of vibrant professionals who are passionate about delivering high quality work for our partners and changing the lives of patients across the globe. If you are driven by innovation, thrive in a fast-paced environment, love to travel and are ready to make a real impact, then Precision for Medicine, Manufacturing Solutions wants you to join our team.

Who Are We?


We are Precision for Medicine, Manufacturing Solutions, the leading advanced therapy technical operations consulting company in the life science industry. As a Patient Focused, People First delivery team, we are committed to advancing manufacturing to achieve operational excellence and accelerate speed to market for next-generation medicines. Our manufacturing playbook has led to the creation of the largest and most mature advanced therapy manufacturing footprint in the world. We are an industry leader in providing project management, validation, engineering, quality/compliance, and consulting services to support our partners across the life science space in finding ground-breaking treatments and solutions.

We believe that our culture of philanthropy, teamwork, training and development and commitment to the patient is the foundation to our teams’ and partners’ long-term success.

Essential Job Function (Include but are not limited to):


  • Create alignment with cross-functional client departments including but not limited to Validation, Manufacturing, Quality, Supply Chain, and Engineering.
  • Provide hands-on support and troubleshooting for clients navigating the engineering life cycle of cutting-edge equipment and manufacturing processes.
  • 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.
  • Proactively identify and escalate roadblocks and utilize critical thinking skills and knowledge of problem-solving skills to identify creative solutions to those problems and roadblocks.
  • Contribute to and embody our Patient Focused and People First Mission through the involvement in professional development and philanthropic opportunities.
  • Build meaningful internal and external relationships presenting Project Farma as a service to clients as needed.

Qualifications:


Education and Experience Required:

  • Bachelor’s degree in Life Science, Engineering, or related discipline and/or comparable military experience.

Other Required:

  • Covid Vaccine is required prior to the Team Member’s start date with exceptions for medical and religious accommodations when reasonable.
  • Full time on-site client presence
  • Willingness to travel up to 100% or as required to support project and business needs.

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$58,000—$63,000 USDAny 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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