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Consultant, Project Controls Engineering

Project FarmaRaleigh, North Carolina, United StatesOnsite

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 Controls Engineer will work collaboratively with clients, vendors, contractors, and other Manufacturing Solutions Team Members to support projects related to biomanufacturing across the entire engineering lifecycle.  The Project Controls Engineer is responsible for delivering high quality work, forming and maintaining valuable, long-term relationships with our clients, and continually strengthening their technical and industry knowledge. They will maintain a strong focus on Manufacturing Solution’s Patient Focused and People First mindset while representing the organization in alignment with our core values.

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


Project Performance and Delivery

  • Create alignment with cross-functional client departments including but not limited to Design, Construction, Validation, Manufacturing, Quality, Supply Chain, and Engineering.
  • Communicate updates internally in a timely manner and relay in-field project decisions to highlight long-range, down-stream project and team impacts.
  • 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.
  • Identify and close individual knowledge gaps with support from other team members, leads, or resources as needed.
  • 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.
  • Support necessary billables as forecasted by site dashboards on billable targets per month.
  • Maintain internal site tools such as site dashboards, deliverable trackers, etc.
  • Continually develop technical aptitude of Manufacturing Solution’s core services within the life science space including but not limited to:
  • Capital Project Management, including Project Controls and Scheduling
  • Facility Builds
  • Tech Transfers
  • Validation Life Cycle, including Commissioning and Qualification, Process Validation, Computer System Validation, etc.
  • Quality, Regulatory, and Compliance
  • GxP Automated Systems
  • Quality Control, including clinical and commercial
  • Have a general understanding of Earned Value Analysis and PO management tool
  • Produce key project controls deliverables including but not limited to:
  • Budget estimates
  • Detailed Project schedules and milestones
  • Feasibility estimates, risks, forecasts and scenario analysis
  • Project cost reports and trend analysis
  • Comprehensive monthly project summary reports
  • Analyze complex project data and then deliver clear, articulate and concise messages in a compelling manner to support decision making.

Leadership and Philanthropy

  • Contribute to and embody our Patient Focused and People First Mission through the involvement in professional development and philanthropic opportunities.
  • Actively seek out opportunities to enhance Manufacturing Solution’s culture, support internal initiatives, and begin to develop servant leadership skills.
  • Seeks opportunities to support the team and leadership.
  • Actively request continuous feedback in order to develop and seek out opportunities for improvement.

Client Management and Business Development:

  • Build meaningful internal and external relationships.
  • Solid Understanding of the Industry and our position within it.
  • Present Project Farma as a service to clients as needed.
  • Continual networking within the industry.
  • Communicate with clients in a professional manner.
  • Ensure any client feedback or opportunities identified are being escalated properly.

Qualifications:


  • Bachelor’s degree in Life Science, Engineering, or related discipline and/or comparable military experience
  • 3-5 years of scheduling and/or project controls experience
  • Experience with Smartsheet's, Microsoft Projects, and/or Primavera highly preferred 
  • 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%
  • 100% onsite presence
  • 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$74,000 - $107,000USDAny 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.It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers.

We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

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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