Validation - Engineer III/Lead - Project Farma
About The Position
Project Farma, a PerkinElmer company, is hiring a full-time salaried Validation Lead Engineer to execute life sciences consulting and engineering project work. The role is an advanced individual-contributor position for an engineer with deep technical expertise and experience leading complex workstreams. The engineer works independently, supports technical decision-making, mentors junior and peer engineers, and partners with project and people leaders without formal people-management responsibilities. The position is based in one of Project Farma’s primary markets and requires domestic travel to client sites as project needs require. The engineer performs commissioning, qualification, and validation (CQV) work; develops and executes validation protocols; tests equipment; troubleshoots systems and manufacturing processes; and authors technical documents. Work must meet client specifications, regulatory requirements such as FDA and GMP, and applicable industry standards. The role also supports project planning and controls, resource coordination, client relationships, business development, and billability goals. Team members are expected to demonstrate curiosity, professionalism, humility, collaboration, a patient-focused mindset, and a commitment to high-quality delivery.
Requirements
- Bachelor’s degree in Life Science, Engineering, or a related discipline, or equivalent work experience in capital project engineering, pharmaceutical cGMP facility start-up, CapEx/OpEx 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.
- Authorization to work in the United States on a full-time basis; the employer will not sponsor current or future work visas.
- Valid driver’s license.
- Ability to work with technical requirements and regulatory frameworks including FDA, GMP, and GxP.
- Ability to communicate clearly and proactively, collaborate with clients and cross-functional teams, manage priorities, and deliver high-quality work.
Nice To Haves
- Full-time on-site presence at client sites.
- Willingness to travel up to 100% or as required.
- Experience with capital project engineering, pharmaceutical cGMP facility start-up, CapEx/OpEx project management, or comparable military experience, where used in place of the listed degree.
Responsibilities
- Execute assigned technical tasks and deliverables to a high standard.
- Perform CQV tasks, including protocol development and equipment testing, under the Site Lead’s guidance.
- Report technical issues to the Site Lead and support resolution efforts.
- Ensure work meets client specifications, regulatory requirements such as FDA and GMP, and industry standards.
- Author SOPs, requirements specifications, testing protocols, summary reports, and other technical documents.
- Identify and address individual knowledge gaps with support from team members or leads.
- Execute system and process validation protocols using GxP best practices.
- Complete assigned project work to support forecast billable targets and maintain 100% individual billability.
- Communicate project updates internally in a timely manner and relay in-field decisions and their downstream impacts.
- Provide hands-on client support and troubleshooting throughout the engineering lifecycle of equipment and manufacturing processes.
- Conduct due diligence on systems and subject domains to produce high-quality project deliverables.
- Identify and escalate roadblocks and apply critical thinking and problem-solving skills to develop solutions.
- Use a general understanding of Earned Value Analysis and project management tools; assist with project controls and scheduling when requested, including estimates, schedules, milestones, risks, forecasts, scenario analyses, and cost reports.
- Coordinate with cross-functional client departments, including Validation, Manufacturing, Quality, Supply Chain, Engineering, and Project Controls.
- Maintain internal site tools such as dashboards and deliverable trackers.
- Continue developing technical aptitude in Project Farma’s life sciences services, including capital project management, tech transfers, validation lifecycles, CQV, computer system validation, quality, regulatory and compliance, GxP automated systems, and clinical and commercial quality control.
- Analyze complex project data and present clear, concise information to support decision-making.
- Develop professionally, support team collaboration, share technical knowledge, and mentor less experienced team members.
- Participate in Project Farma’s internal qualification training program.
- Support site strategy under the Site Lead’s direction by completing assigned tasks aligned with Project Farma’s services and strategic objectives.
- 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.
- Provide task-level resource input to the Site Lead, report workload or skill gaps, and communicate resource constraints affecting project schedules.
- Deliver high-quality work that supports project success and business growth; build internal and external relationships and present Project Farma’s services to clients as needed.
- Communicate professionally with clients and escalate client feedback and identified opportunities.
- Provide project progress and risk information to the Site Lead for dashboards or expansion discussions.
- Support project extensions and proposals by preparing client deliverables.
- Identify opportunities to cross-sell or upsell Project Farma services beyond Validation.
- Escalate roadblocks that may prevent achievement of billable targets.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
