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PerkinElmer

Analytical instruments and software for health

Validation Engineer 3/Lead

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time$80k - $115k /yr

About the Job

Requirements

  • A bachelor's degree in Life Science, Engineering, or a related discipline, or equivalent work experience in capital project engineering, pharmaceutical cGMP facility start-up, capital/operational expenditure project management, or comparable military experience.
  • Four 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 project tasks and produce high-quality deliverables.
  • Perform commissioning, qualification, and validation tasks, including 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 Food and Drug Administration and Good Manufacturing Practice requirements, and industry standards.
  • Author standard operating procedures, requirements specifications, testing protocols, summary reports, and other technical documents.
  • Identify and close individual knowledge gaps with support from other team members or leads as needed.
  • Execute system and process validation protocols using GxP best practices.
  • Support forecasted billable work based on site dashboard targets.
  • Communicate updates internally in a timely manner and relay in-field project decisions, including their long-range and downstream project and team impacts.
  • Provide hands-on support and troubleshooting for clients working through the engineering life cycle of equipment and manufacturing processes.
  • Perform due diligence on systems and subject domains to generate high-quality project deliverables.
  • Identify and escalate roadblocks, and use critical thinking and problem-solving skills to develop solutions.
  • Apply a general understanding of Earned Value Analysis and project management tools.
  • As requested, assist with project controls and scheduling, including budget estimates, detailed schedules and milestones, feasibility estimates, risk and forecast analysis, 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 such as site dashboards and deliverable trackers.
  • Continually develop technical aptitude in Project Farma's life sciences services, including capital project management, technology transfers, validation life cycles including commissioning, qualification, and validation 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.
  • Participate in Project Farma's internal qualification training program.
  • Support execution of site strategy under the Site Lead's direction by completing specific project tasks aligned with Project Farma's services.
  • Perform assigned tasks to meet strategic objectives, such as preparing and executing commissioning, qualification, and validation protocols.
  • Identify and report client needs or project challenges to the Site Lead.
  • 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.
  • Report workload or skill gaps within assigned tasks.
  • Assist in maintaining project schedules by communicating resource constraints.
  • Deliver high-quality work that supports project success and business growth opportunities.
  • Build internal and external relationships.
  • Present Project Farma's services to clients as needed.
  • Communicate professionally with clients.
  • Escalate client feedback and identified opportunities appropriately.
  • Provide project progress and risk data or insights to the Site Lead for dashboards or expansion discussions.
  • Participate in project tasks that support extensions or proposals, such as preparing client deliverables.
  • Identify opportunities to cross-sell and upsell 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.
  • 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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