CQV Project Engineer /Senior Engineer - Project Farma
Job Description
Responsibilities
Location Raleigh, North Carolina US Job ID REQ-057145This is a full-time salaried position with Project Farma, a PerkinElmer company. The successful candidate willreside in the Raleigh area market and be willing to travel domestically, to meet client project requests.
The Project Engineer is a fully billable role that will work collaboratively with clients, vendors, contractors, andother Team Members to support projects related to biomanufacturing across the entire engineering lifecycle. TheProject Engineer is responsible for delivering high quality work, forming and maintaining valuable, long-termrelationships with our clients, and continually strengthening their technical and industry knowledge. They willmaintain a strong focus on Project Farma's Patient Focused and People First mindset.
SSite Strategy
- Support the execution of site strategy under the direction of the Site Lead, contributing to specific projecttasks that align with Project Farma's services.
- Perform assigned tasks to meet strategic objectives, such as preparing and executing CQV Protocols
- Identify and reports client needs or project challenges to the Site Lead for further action.
- Maintain professional relationships with project team members and client POCs at the operational level(e.g., technicians, engineers) to facilitate task completion.
Business Growth & Development
- Contribute to project-level success by delivering high-quality work that supports business growthopportunities.
- Provides data or insights (e.g., project progress, risks) to the Site Lead for inclusion in dashboards orexpansion discussions.
- Participate in project tasks that support extensions or proposals, such as preparing deliverables for clients.
- Build meaningful internal and external relationships.
- Present Project Farma as a service to clients as needed.
- Communicate with clients in a professional manner.
- Ensure any client feedback or opportunities identified are being escalated properly.
Talent Development
- Focus on professional development and support team collaboration under the Site Leads guidance.Share technical knowledge with peers to support project delivery.
- Resource Management
- Provide input on task-level resource needs to the Site Lead to support project delivery.
- Report workload or skill gaps within assigned tasks.
- Assist in maintaining project schedules by communicating resource constraints.
Technical Delivery
- Create alignment with cross-functional client departments including but not limited to Validation,
- Manufacturing, Quality, Supply Chain, Engineering and Project Controls
- Communicate updates internally in a timely manner and relay in-field project decisions to highlight longrange, down-stream project and team impacts.
- Provide hands-on support and troubleshooting for clients navigating the engineering life cycle of cuttingedge equipment and manufacturing processes.
- Perform due diligence on system and subject domains to generate high-quality project deliverables.
- Execute specific technical tasks within a project, ensuring high-quality deliverables.
- Perform CQV tasks, such as protocol development or equipment testing, under the Site Lead's guidance.
- Report technical issues to the Site Lead and support resolution efforts.
- Ensure tasks meet client specifications, regulatory requirements (e.g., FDA, GMP), and industry standards.
- Author technical documents: SOPs, requirements specifications, testing protocols, summary reports, etc.
- Identify and close individual knowledge gaps with support from other team members or leads as needed.
- Execute system and process validation protocols by using GxP best practices.
- Proactively identify and escalate roadblocks and utilize critical thinking skills and knowledge of problemsolving 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 Project Farma's core services within the life science spaceincluding but not limited to: Capital Project Management, Facility Builds, Tech Transfers, Validation Life
- Cycles including CQV and Computer system Validation, Quality, Regulatory and Compliance, GxP
- Automated Systems, and Quality Control including clinical and commercial.
- General understanding of Earned Value Analysis (EVA) and PO management tool
- Analyze complex project data and then deliver clear, articulate and concise messages in a compellingmanner to support decision making.
- May be requested to assist with Project Controls and Scheduling to include; Budget estimates, detailedproject schedules and milestones, feasibility estimates, risks, forecasts and scenario analysis and projectcost reports and analysis.
Operational Performance & Billability
- Maintain 100% individual billability by completing assigned project tasks.
- Escalate any roadblocks on achieving billable targets to the site lead.
Experience Required
0-4 years' experience in consulting and/or engineering services.
Bachelor's Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent workexperience in CQV engineering, cGMP facility start-up, project management and/or comparable militaryexperience).
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. Allqualified 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 othercharacteristics 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 currentor 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.
Responsibilities
Location Raleigh, North Carolina US Job ID REQ-057145This is a full-time salaried position with Project Farma, a PerkinElmer company. The successful candidate willreside in the Raleigh area market and be willing to travel domestically, to meet client project requests.
The Project Engineer is a fully billable role that will work collaboratively with clients, vendors, contractors, andother Team Members to support projects related to biomanufacturing across the entire engineering lifecycle. TheProject Engineer is responsible for delivering high quality work, forming and maintaining valuable, long-termrelationships with our clients, and continually strengthening their technical and industry knowledge. They willmaintain a strong focus on Project Farma's Patient Focused and People First mindset.
SSite Strategy
- Support the execution of site strategy under the direction of the Site Lead, contributing to specific projecttasks that align with Project Farma's services.
- Perform assigned tasks to meet strategic objectives, such as preparing and executing CQV Protocols
- Identify and reports client needs or project challenges to the Site Lead for further action.
- Maintain professional relationships with project team members and client POCs at the operational level(e.g., technicians, engineers) to facilitate task completion.
Business Growth & Development
- Contribute to project-level success by delivering high-quality work that supports business growthopportunities.
- Provides data or insights (e.g., project progress, risks) to the Site Lead for inclusion in dashboards orexpansion discussions.
- Participate in project tasks that support extensions or proposals, such as preparing deliverables for clients.
- Build meaningful internal and external relationships.
- Present Project Farma as a service to clients as needed.
- Communicate with clients in a professional manner.
- Ensure any client feedback or opportunities identified are being escalated properly.
Talent Development
- Focus on professional development and support team collaboration under the Site Leads guidance.Share technical knowledge with peers to support project delivery.
- Resource Management
- Provide input on task-level resource needs to the Site Lead to support project delivery.
- Report workload or skill gaps within assigned tasks.
- Assist in maintaining project schedules by communicating resource constraints.
Technical Delivery
- Create alignment with cross-functional client departments including but not limited to Validation,
- Manufacturing, Quality, Supply Chain, Engineering and Project Controls
- Communicate updates internally in a timely manner and relay in-field project decisions to highlight longrange, down-stream project and team impacts.
- Provide hands-on support and troubleshooting for clients navigating the engineering life cycle of cuttingedge equipment and manufacturing processes.
- Perform due diligence on system and subject domains to generate high-quality project deliverables.
- Execute specific technical tasks within a project, ensuring high-quality deliverables.
- Perform CQV tasks, such as protocol development or equipment testing, under the Site Lead's guidance.
- Report technical issues to the Site Lead and support resolution efforts.
- Ensure tasks meet client specifications, regulatory requirements (e.g., FDA, GMP), and industry standards.
- Author technical documents: SOPs, requirements specifications, testing protocols, summary reports, etc.
- Identify and close individual knowledge gaps with support from other team members or leads as needed.
- Execute system and process validation protocols by using GxP best practices.
- Proactively identify and escalate roadblocks and utilize critical thinking skills and knowledge of problemsolving 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 Project Farma's core services within the life science spaceincluding but not limited to: Capital Project Management, Facility Builds, Tech Transfers, Validation Life
- Cycles including CQV and Computer system Validation, Quality, Regulatory and Compliance, GxP
- Automated Systems, and Quality Control including clinical and commercial.
- General understanding of Earned Value Analysis (EVA) and PO management tool
- Analyze complex project data and then deliver clear, articulate and concise messages in a compellingmanner to support decision making.
- May be requested to assist with Project Controls and Scheduling to include; Budget estimates, detailedproject schedules and milestones, feasibility estimates, risks, forecasts and scenario analysis and projectcost reports and analysis.
Operational Performance & Billability
- Maintain 100% individual billability by completing assigned project tasks.
- Escalate any roadblocks on achieving billable targets to the site lead.
Experience Required
0-4 years' experience in consulting and/or engineering services.
Bachelor's Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent workexperience in CQV engineering, cGMP facility start-up, project management and/or comparable militaryexperience).
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. Allqualified 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 othercharacteristics 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 currentor 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.
About PerkinElmer
For 85 years, PerkinElmer has pushed the boundaries of science from food to health to the environment. We’ve always pursued science with a clear purpose – to help our customers achieve theirs. Our expert team brings technology and intangibles, like creativity, empathy, diligence, and a spirit of collaboration, in equal measure, to fulfill our customers’ desire to work better, innovate better, and create better.
PerkinElmer is a leading, global provider of technology and service solutions that help customers measure, quantify, detect, and report in ways that help ensure the quality, safety, and satisfaction of their products.
