Sr. Process Engineer

Johnson & Johnson•Jacksonville, FL

5d•Onsite

About The Position

The Sr. Process Engineer provides technical leadership as part of Product/Process Engineering within the broader contact lens supply chain organization. The role leads complex engineering projects and initiatives supporting safety, quality, delivery, cost, and innovation objectives in a regulated (GMP/ISO/FDA) environment. This individual is accountable for end-to-end execution of process characterization, change control, and validation/qualification activities (IQ/OQ/PQ), technical investigations, continuous improvement, and cross-functional delivery.

Requirements

Bachelors degree in Chemical Engineering, Materials Science Engineering, or related technical subject area
A minimum of 4 years of relevant engineering experience in a manufacturing, operations, R&D, or similar regulated industry environment
Demonstrated experience leading projects of moderate-to-high complexity (multi-functional scope, qualification/validation, change control)
Strong analytical and structured problem solving capability; ability to interpret data, identify trends, and drive decisions using risk-based thinking
Proven technical writing capability and disciplined application of good documentation practices
Demonstrated leadership abilities in multi-functional environment; effective communication and influencing across organizational levels and external partners
Ability to work independently with limited supervision while effectively demonstrating multi-functional collaboration
English proficiency is required

Nice To Haves

Demonstrated experience leading characterization, qualification/validation, and change control from strategy initiation through closure in a med-device or similar industry environment
Certification in Six Sigma methodologies (Green Belt or Black Belt)
Familiarity with statistical analysis software such as JMP or Minitab
Polymers/polymer chemistry familiarity or exposure

Responsibilities

Leads and delivers complex engineering and/or change control projects requiring concept evaluation, design, and validation. Applies project management methodologies to define scope, schedule, resources, risks, and objectives; drives timely execution and closure.
Performs concept analysis and supports development of capital/expense project justifications for future project development.
Participates in and/or leads technical design reviews; translates requirements into robust manufacturing/product/equipment specifications.
Plans and delivers qualification of new or modified equipment, controls, systems, processes, and/or packaging operations; supports vendor and site acceptance testing (FAT/SAT) as required.
Leads validation strategy and execution (IQ/OQ/PQ), including protocol authoring, execution oversight, deviation management, and report approval.
Ensures high-quality technical documentation (protocols, reports, risk assessments, work instructions, specifications) in compliance with GDP and internal/regulatory standards.
Identifies and implements process, equipment, packaging, and/or materials enhancements that improve efficiency, yield, reliability, robustness, and safety.
Designs and implements characterization studies and experiments using statistical/analytical tools (e.g., DOE, capability, stability, trending) to set new performance standards and drive breakthrough improvements.
Leads structured problem solving and root cause analysis for complex quality, technical, and manufacturing issues (e.g., deviations, non-conformances, audit actions, CAPAs).
Partners with Operations and Quality to implement corrective/preventive actions and sustain improvements; ensures effective risk assessments and controls.
Provides training and technical guidance to engineers, technicians, and operations personnel to enable safe operation, troubleshooting, and maintenance of processes/equipment.
Provides mentoring and technical guidance to junior engineers, interns, and/or co-ops; builds capability within the team.
Demonstrates technical depth and influence within the functional team; serves as a change agent by promoting a learning culture and continuous improvement approach.
Ensures alignment to all applicable quality/compliance regulations, standards, and company policies; maintains the highest standards of professionalism, ethics, and compliance.
Supports and advances compliance program-related initiatives within the function.