Senior Validation Engineering Consultant II

Senior Validation Engineering Consultant II

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 Consultant will work collaboratively with clients, vendors, contractors, and other Manufacturing Solutions 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 through Manufacturing Solution’s Patient Focused and People first platform. This is accomplished through overseeing high-quality deliverables, supporting and escalating business development opportunities, and continually strengthening their technical and industry knowledge. Essential functions of the job include but are not limited to: Project Performance and Delivery Coordinate with cross-functional client departments including but not limited to Validation, Manufacturing, Quality, Supply Chain, and Engineering to:

Lead, oversee, and execute client project initiatives, plans, or workstreams including ensuring team deliverables are completed in a timely and high-quality fashion. Coach Team Member on identified knowledge gaps and direct Team Members to materials to develop project driven technical and problem-solving skills. Develop, execute, and delegate project strategy, initiatives, and vision to effectively lead a small project team. Provide hands-on support for both clients and PF Team Members in navigating the 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 and protocols. Build internal and external understanding, buy-in, and commitment to decisions through mutual understanding, collaboration, and effective presentations skills. Mentor and train internal PF Team Members on assigned duties, industry best practices, overall understanding of the business, and project driven technical skills. Generate project succession plans as identified by leadership. Maintain and present site dashboards to communicate project health and maintenance. Support Site and Account Leads in proposal generation. Maintain PO management tools and proactively communicate PO performance. Coordinate Team Member utilization with Site and Account Leads and communicate and escalate discrepancies between actual and forecasted utilization. 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

Leadership and Philanthropy Contribute to and embody our Patient Focused and People First Mission ensuring philanthropic and professional development opportunities are available for their site. Coach and mentor Team Members on solution driven mindset. Collaboratively support and provide input for the succession of future Project Leads through a continual emphasis on training, mentorship, servant leadership, and technical skill development. Build and maintain professional networks for business development and recruiting purposes. Actively seeks out opportunities to enhance Manufacturing Solution’s culture, support internal initiatives, and continue to develop servant leadership skills. Build and maintain deep rooted and meaningful internal and external relationships. Provide continuous performance feedback and proactively manage Team Member performance escalating when appropriate. Identify and delegate project tasks for Team Member development. Client Management and Business Development Support Manufacturing Solution’s business development initiatives through proactively identifying and escalating client needs along with a proposed support plan to their Lead appropriately. Understand and be able to speak to PF services both internally and externally. Support in generation of proposals in collaboration with Site and Account Leads. Identify additional opportunities for client support. Foster positive relationships with key stakeholders. Generate proposed support plan and escalate that plan to Site and Account Leads to maintain up-to-date site’s business development dashboard. Qualifications: Bachelor’s degree in Life Sciences, Engineering, or related discipline and/or comparable military experience. A minimum of 5 years of Project Engineer, Consulting, and/or relevant industry experience. Other Required: Full COVID-19 vaccination is required prior to the Team Member's start date with exceptions for medical and religious accommodations when reasonable. Willingness to travel and/or relocate for the first 2 years. Up to 100% on-site presence. Preferred : Customer Focused:

Able to identify, prioritize, and escalate client needs and recognize constraints. Seeks to find out more about our clients, build meaningful relationships with clients, and provide excellent service towards the customer. P

roblem Solving:

Able to identify key components of problems, generate and evaluate proposed solutions or mitigation plans, and choose the most appropriate option. Teamwork and Collaboration : Active participant in team environment and works together towards a common vision and/or goal. Encourages and embraces cooperation and collaboration amongst teams. Initiative : Able to complete deliverables or work unassisted. Takes responsibility for their own time and productivity. Actively seeks out new things to learn. Flexibility and Adaptability:

Able to respond positively to and communicate change to teams. Adapt to new situations quickly. Able to take on a diverse range of tasks while remaining equally effective. Handles competing demands, overcomes setbacks, welcomes, and learns from constructive feedback. Integrity : Demonstrates commitment to corporate and personal values. Takes accountability for their actions, decisions, and work. Exhibits a high standard of ethics. Builds and maintains trust and good working relationships. Demonstrates honesty and truthfulness at all times. Accountability:

Demonstrates a high level of self-awareness. Holds self and others accountable for measurable, high-quality, timely, and effective results. Determines objectives, sets priorities, and delegates work through to the end. Leading and Developing Others : Ability to communicate effectively, mentor and develop others, and build and maintain relationships. Proactively identify performance trends and developmental and/or stretch opportunities for Team Members. 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 $93,000

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