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PerkinElmer

Analytical instruments and software for health

Validation Engineer 3 / Lead Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time$71k - $106k /yr

About the Job

Requirements

  • A bachelor's degree in Life Science, Engineering, or a related discipline is required, or equivalent work experience in capital project engineering, pharmaceutical cGMP facility start-up, CapEx/OpEx project management, or comparable military experience.
  • Two to seven years of experience in consulting and/or engineering services.
  • Willingness to travel as required for client project assignments.
  • Applicants must be authorized to work in the United States on a full-time basis.
  • A valid driver's license is required.

Responsibilities

  • Execute assigned technical tasks within projects and ensure high-quality deliverables.
  • Perform commissioning, qualification, and validation (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 such as FDA and good manufacturing practices (GMP), and industry standards.
  • Author technical documents, including standard operating procedures (SOPs), requirements specifications, testing protocols, and summary reports.
  • Identify and close individual knowledge gaps with support from team members or leads as needed.
  • Execute system and process validation protocols using good practice (GxP) best practices.
  • Support billable work as forecasted by site dashboards and monthly billable targets.
  • Communicate updates internally in a timely manner and relay in-field project decisions, highlighting long-range and downstream project and team impacts.
  • Provide hands-on support and troubleshooting for clients navigating the engineering life cycle of equipment and manufacturing processes.
  • Perform due diligence on systems and subject domains to generate high-quality project deliverables.
  • Proactively identify and escalate roadblocks and use critical thinking and problem-solving skills to identify solutions.
  • Use general understanding of Earned Value Analysis (EVA) and project management tools.
  • Assist with project controls and scheduling as requested, including budget estimates, detailed project schedules and milestones, feasibility estimates, risks, forecasts, scenario analysis, and project cost reports and analysis.
  • Align with cross-functional client departments, including Validation, Manufacturing, Quality, Supply Chain, Engineering, and Project Controls.
  • Maintain internal site tools, including site dashboards and deliverable trackers.
  • Continually develop technical aptitude in Project Farma's core life-sciences services, including capital project management, tech transfers, validation life cycles including CQV and computer system validation, Quality, Regulatory and Compliance, GxP automated systems, and Quality Control for clinical and commercial work.
  • Analyze complex project data and deliver clear, concise messages to support decision-making.
  • Focus on professional development and support team collaboration under the Site Lead's guidance.
  • Share technical knowledge with peers and mentor less experienced team members to support project delivery.
  • Participate in Project Farma's internal qualification training program.
  • Support site strategy execution under the Site Lead's direction by contributing to project tasks aligned with Project Farma's services.
  • Perform assigned tasks to meet strategic objectives, such as preparing and executing CQV protocols.
  • Identify and report client needs or project challenges to the Site Lead for further action.
  • Maintain professional relationships with project team members and client points of contact at the operational level, such as technicians and engineers, to facilitate task completion.
  • 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.
  • Contribute to project-level success through high-quality work that supports business growth opportunities.
  • Build meaningful internal and external relationships.
  • Present Project Farma as a service to clients as needed.
  • Communicate with clients in a professional manner.
  • Escalate client feedback or identified opportunities appropriately.
  • Provide project progress and risk data or insights to the Site Lead for dashboards or expansion discussions.
  • Participate in project tasks supporting extensions or proposals, such as preparing client deliverables.
  • Identify opportunities to cross-sell and up-sell Project Farma services outside the Validation discipline.
  • Maintain 100% individual billability by completing assigned project tasks.
  • Escalate roadblocks to achieving billable targets to the Site Lead.

Desired Qualifications

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

About the Company

PerkinElmer

Analytical instruments and software for health

PerkinElmer provides analytical instruments, software, and services for the life sciences, diagnostics, and environmental health markets. Customers use these tools to collect and analyze data through a combination of hardware, consumable supplies, and software licensing. Unlike many competitors, the company integrates a global service network with a focus on sustainability by designing products that reduce waste and energy consumption. Its goal is to improve human and environmental health by helping laboratories and industrial companies achieve more efficient and accurate scientific results.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Shelton, CT
Founded
1937

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