Manufacturing & Tech Ops - Lead Engineer - Project Farma
About The Position
This is a full-time salaried position with Project Farma, a PerkinElmer company. The successful candidate will reside in Maryland and be willing to travel domestically to meet client project requests. Project Farma’s purpose is to improve patient lives by accelerating the delivery of life-changing therapies. We accomplish this through the successful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management. This role contributes to organizational success by supporting financial performance, operational efficiency, and continuous improvement, while also investing in people through mentorship, knowledge sharing, and professional development. All team members are expected to embody Project Farma’s values by being curious, personable, and unselfish, while maintaining a strong commitment to a Patient Focused and People First mindset. The Manufacturing & Tech Ops - Lead Engineer is an advanced individual contributor with demonstrated depth in their technical discipline and a growing record of leading complex workstreams. This role applies strong subject‑matter expertise to solve high‑impact technical and operational challenges, supports technical decision‑making, and contributes to the evolution of standards, methods, or best practices within their area. The Lead Engineer works with a high degree of independence, mentors junior and peer engineers, and partners closely with project and people leaders—while remaining focused on technical delivery rather than formal people management.
Requirements
- Bachelor’s Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in capital project engineering, pharma cGMP facility start-up, CapEx/OpEx project management and/or comparable military experience).
- 4-7 years of experience in engineering or operations within pharmaceutical, biotech, or regulated manufacturing environments.
- Strong understanding of pharmaceutical development and manufacturing processes (biologics, small molecule, or both).
- Ability to interpret technical documentation and engineering drawings.
- Working knowledge of cGMP regulations (FDA 21 CFR Parts 210/211, ICH guidelines, EMA requirements).
- Exceptional organizational, communication, and stakeholder management skills.
- Proven ability to manage multiple priorities and drive results in a fast-paced, matrixed environment.
- Willingness to travel as required for client project assignments.
Nice To Haves
- Certification in First Aid or CPR
- Familiarity with ISO standards and FDA audit processes.
- Experience supporting equipment qualification (IQ/OQ/PQ).
- Experience with aseptic processing is a plus
- Familiarity with regulatory submission processes (IND, BLA, NDA, MAA).
- Six Sigma, Lean, or other continuous improvement certification.
Responsibilities
- Lead or Support end-to-end program management for complex technical operations initiatives including new product introductions, technology transfers, process validations, and facility fit assessments.
- Develop integrated program plans, critical path analyses, risk registers, and resource plans; proactively identify and escalate risks and issues.
- Contribute to the completion of stage-gate processes and governance deliverables, ensuring milestones are met on time, within scope, and aligned to regulatory commitments.
- Coordinate or work with cross-functional workstreams across Manufacturing, Process Development, Quality, Regulatory Affairs, Supply Chain, and Engineering.
- Partner with technical subject matter experts to translate scientific and process requirements into executable operational plans, development of staff awareness of critical process parameters (CPP) and critical quality attributes (CQA).
- Support technology transfer activities from development into GMP manufacturing, including documentation, gap assessments, and readiness reviews.
- Facilitate resolution of technical, operational, and quality issues that arise during operations, startup or shutdown of manufacturing equipment.
- Development of manufacturing batch records, SOPs or validation protocols As required.
- Perform operational readiness assessments that fully evaluate equipment suitability and reliability, facility fit and finish, material workflow, supply chain planning, training materials and programs, quality and compliance, sampling plans, area risk assessments and personnel PPE/gowning requirements, cleaning procedures and frequency, tier communication plans, warehouse operations and operational planning that incorporates planned downtime for necessary asset maintenance and repair.
- Support the primary point of contact and program communicator in their efforts to align with senior leadership, cross-functional partners, and external collaborators or CDMOs.
- Drive alignment across stakeholders with competing priorities; facilitate trade-off discussions and decision-making.
- Support the development and deployment of program management frameworks, tools, and best practices across the organization.
- Coach and develop a team of technical professionals to deliver high‑quality work aligned with project, client, and business objectives.
- Other duties as assigned
Benefits
- Full-time salaried position
- PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer.
- PerkinElmer is committed to a culturally diverse workforce.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
