Manufacturing & Tech Ops – Engineer III/Lead Engineer

PerkinElmer

. 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 .

Posted 9/29/2026full-timeUnited StatesSenior💰 $74,000 - $113,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in program management for complex technical operations within pharmaceutical and biotech environments, focusing on regulatory compliance, process validation, and cross-functional collaboration. Proficient in developing operational plans, managing risks, and ensuring alignment with senior leadership and stakeholders.

Highest-signal resume keywords

Program ManagementCGMP RegulationsPharmaceutical DevelopmentStakeholder ManagementOperational Readiness Assessments

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Program PlanningRisk ManagementProcess ValidationTechnical Documentation InterpretationManufacturing Batch Records DevelopmentSOP DevelopmentEquipment QualificationAseptic ProcessingRegulatory Submission ProcessesCritical Path Analysis

Soft Skills

Organizational SkillsCommunication SkillsMentorshipProblem-SolvingCollaboration

Certifications & Qualifications

First Aid CertificationCPR CertificationSix Sigma CertificationLean Certification

Industry Keywords

Pharmaceutical ManufacturingBiotechRegulated ManufacturingGMPISO StandardsFDA Audit ProcessesINDBLANDAMAA

About the role

Key responsibilities & impact

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; identify and escalate risks and issues
Contribute to stage-gate processes and governance deliverables, ensuring milestones are met on time, within scope, and aligned to regulatory commitments
Coordinate cross-functional workstreams across Manufacturing, Process Development, Quality, Regulatory Affairs, Supply Chain, and Engineering
Translate scientific and process requirements into executable operational plans and develop staff awareness of critical process parameters and critical quality attributes
Support technology transfer activities from development into GMP manufacturing, including documentation, gap assessments, and readiness reviews
Facilitate resolution of technical, operational, and quality issues during manufacturing equipment operations, startup, or shutdown
Develop manufacturing batch records, SOPs, and validation protocols as required
Perform operational readiness assessments covering equipment, facility fit and finish, material workflow, supply chain planning, training, quality and compliance, sampling plans, risks, PPE/gowning, cleaning, communications, warehousing, and maintenance planning
Support program communication and alignment with senior leadership, cross-functional partners, and external collaborators or CDMOs
Drive stakeholder alignment, trade-off discussions, and decision-making
Support development and deployment of program management frameworks, tools, and best practices
Coach and develop technical professionals to deliver high-quality work
Contribute to financial performance, operational efficiency, continuous improvement, mentorship, knowledge sharing, and professional development
Perform other duties as assigned

Requirements

What you’ll need

Bachelor’s Degree in Life Science, Engineering, or related discipline, or equivalent work experience in capital project engineering, pharma cGMP facility start-up, CapEx/OpEx project management and/or comparable military experience
2-7 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
Applicants must be authorized to work in the United States on a full-time basis
PerkinElmer will not sponsor applicants for current or future work visas
Position may require significant travel
Valid driver's license required; applicants with an invalid driver's license cannot be employed
Certification in First Aid or CPR preferred
Familiarity with ISO standards and FDA audit processes preferred
Experience supporting equipment qualification (IQ/OQ/PQ) preferred
Experience with aseptic processing is a plus
Familiarity with regulatory submission processes (IND, BLA, NDA, MAA) preferred
Six Sigma, Lean, or other continuous improvement certification preferred

Benefits

Comp & perks

Equal opportunity employer and commitment to a culturally diverse workforce