Validation Engineering (pharma) Consultant - Project Farma

Responsibilities

Location Raleigh, North Carolina US Job ID REQ-057103

This is a full-time salaried position with Project Farma, a PerkinElmer company. The successful candidate will reside in the Raleigh-Durham market and be willing to travel domestically, to meet client project requests.

The Consultant will work collaboratively with clients, vendors, contractors, and other Team Members to lead and support projects related to biomanufacturing across the entire project lifecycle. Specifically, they are responsible for leading and mentoring small project teams and identifying business development opportunities through Project Farma's Patient Focused and People First platform. The Consultant is a tactical executor focused on project-level delivery, supporting the site Manager's strategy, and contributing to business growth, talent development, and resource planning with an emphasis on technical expertise and operational execution. They will maintain a strong focus on Project Farma's Patient Focused and People First mindset.

Key Responsibilities

Site Strategy

• Executes the site strategy as defined by the Manager to support the firm's leadership position in CQV services.
• Identifies client needs during project execution and communicates these to the Manager for strategic consideration.
• Builds and maintains relationships with key project Points of Contact (POCs), such as project managers or technical leads, to ensure smooth project delivery and client satisfaction.
  
  

Business Growth & Development

• Participate in project extensions and proposal generation, providing technical and operational input.
• Attend market-based industry events to build a local network.
• Provide deliverable and resource recommendations for site proposals to ensure feasibility.
• Support Project Farma's business development initiatives through proactively identifying and escalating client needs along with a proposed support plan to their Manager appropriately.
• Understand and be able to speak to services both internally and externally.
• Maintain and present site dashboards to communicate project health, growth opportunities, and account maintenance needs.
• Communicate opportunities to expand presence and services for client support.
• Foster positive relationships with key stakeholders.
• Generate proposed support plan and escalate that plan as needed.
• Learn and develop skills and understanding of the business development process including proposal generation.
  
  

Talent Development

• Encourage team members to share best practices within the team or site, contributing to a collaborative culture.
• Foster accountability and excellence within the project team and communicates retention risks (e.g., team morale issues) to the Manager.
• Develop and maintain your own succession plan to ensure project continuity.
  
  

Technical Delivery

• Escalate technical delivery issues to the Manager and provide resolution or mitigation solutions.
• Ensure delivery of high-quality GMP Engineering services that meet client specifications, regulatory requirements, and industry standards.
• Support project execution, from planning to closeout, ensuring timelines and budgets are met.
• Lead, oversee, and execute client project initiatives, plans, or workstreams including ensuring team deliverables are completed in a timely and high-quality fashion.
• Provide hands-on support for both clients and Project Farma Team Members in navigating the engineering life cycle of cutting-edge equipment and manufacturing processes including proactively identifying and escalating roadblocks and utilizing critical thinking skills and knowledge of problem-solving skills to identify creative solutions.
• Create, update, and present work projections and progress reports.
• Develop technical documentation such as SOPs, requirements specifications, testing protocols, summary reports, etc.
• Build internal and external understanding, buy-in, and commitment to decisions through mutual understanding, collaboration, and effective presentations skills.
• Maintain PO management tools; managing burn rates; needs for new proposals and proactively communicate PO performance.
• Coordinate Team Member utilization with Site and Account Leads and escalate discrepancies between actual and forecasted utilization.
• Maintain internal site tools such as site dashboards, deliverable trackers, etc.
• Continually develop technical aptitude of Project Farma'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 CQV Process, Computer System Validation, Quality, Regulatory, and Compliance, GxP Automated Systems, Quality Control, including Clinical and Commercial.
• May be requested to assist with Project Controls and Scheduling to include: budget estimates, detailed project schedules, feasibility estimates, risks and forecast analysis as well as project cost reports and trends.
  
  

Operational Performance & Billability

• Maintains 100% individual billability, focusing on personal contribution to project hours.
• Provides input into resourcing decisions for the project team to ensure high-quality delivery.
• Consults with Manager to forecast future resource needs for the project and contribute to the resource plan.
  
  

Experience Required

• 4-10 years' experience in consulting and/or engineering services.
• 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).
  
  

Other Required

• Full-time on-site client presence
• Willingness to travel up to 100% or as required
  
  

Project Farma is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position. This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license.

VEVRAA Federal Contractor.

We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.

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