Senior Process Engineering

Johnson & Johnson Innovative Medicine•Añasco, PR

5d•Onsite

About The Position

The Senior Engineer provides technical leadership within an assigned manufacturing value stream and/or engineering function (e.g., Process, Packaging, Materials/Supplier, Equipment/Validation). The role leads complex engineering projects and initiatives supporting safety, quality, delivery, cost, and innovation objectives in a regulated (GMP/ISO/FDA) environment. The Senior Engineer is accountable for end-to-end execution of change control and validation/qualification activities (IQ/OQ/PQ as applicable), technical investigations, continuous improvement, and cross-functional delivery. Responsibilities and accountabilities may vary by site. Applicable procedures and quality systems (e.g., QUMAS/eDMS where applicable) define responsibilities and may supersede elements of this position description. The Senior Engineer is responsible for providing technical leadership within an assigned area and may have ownership for the following (as applicable to assignment):

Requirements

Bachelor’s degree in Engineering is required.
A minimum of 4 years of related work experience is required.
Demonstrated experience leading projects of moderate-to-high complexity (cross-functional scope, qualification/validation, change control).

Nice To Haves

Advanced degree (Master’s) in Engineering/Science.
Experience leading qualification/validation (IQ/OQ/PQ) and change control from strategy through closure in regulated environments.
Demonstrated experience applying statistical tools/experimental design (DOE) and continuous improvement methodologies (Lean/Six Sigma).
For packaging assignments: demonstrated knowledge/experience with sterile barrier packaging systems and applicable standards/test methods (e.g., ISO 11607, ASTM/ISTA); experience supporting audits in functional area.
For materials/supplier assignments: demonstrated materials science expertise (e.g., polymers), supplier qualification experience, and material characterization methodology experience.
Proficiency with standard office tools (Excel/PowerPoint/Project as applicable) and familiarity with statistical analysis software (e.g., JMP/Minitab) preferred.

Responsibilities

Leads and executes complex engineering and/or change control projects requiring conceptual evaluation, design, and validation. Applies project management methodologies to define scope, schedule, resources, risks, and deliverables; 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 executes complex 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 executes characterization studies and experiments using statistical/analytical tools (e.g., DOE, capability, stability, trending) to set new performance standards and drive breakthrough improvements. For packaging-focused assignments: leads packaging system design/development/validation and maintenance activities; qualifies packaging components/systems; establishes packaging specifications; leads packaging process/equipment validations; and supports labeling/packaging improvements aligned with applicable standards and regulatory requirements. For materials/supplier-focused assignments: serves as functional SME; leads material characterization, worst-case/challenge testing and qualification activities for new/revised materials and suppliers; supports business continuity planning (BCP) initiatives related to materials/suppliers; and provides technical support to resolve material-related issues.
Leads structured problem solving and root cause analysis for complex quality, technical, and manufacturing issues (e.g., deviations, nonconformances, 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 mindset.
Ensures adherence to all applicable regulations, standards, and company policies; maintains the highest standards of professionalism, ethics, and compliance. Supports and advances compliance program-related initiatives within the function.