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Principal Engineer responsible for developing engineering specifications, product requirements, system architectures, characterization plans, verification and validation protocols, and process development documentation for pharmaceutical and combination products. Leads projects through PPQ approval, supports testing and optimization, assesses technical risks, and collaborates with Operations, Engineering, and Automation teams. Provides technical guidance to junior engineers while managing multiple deadline-driven projects.

Responsible for mapping manufacturing processes and creating, updating, and maintaining technical documentation, including procedures, work instructions, and process flow diagrams. Collaborates with cross-functional teams to validate process details, identify documentation gaps, and recommend improvements. Ensures documentation complies with document control and quality system requirements. The role requires an engineering or science degree, at least two years of relevant experience, intermediate English, strong communication skills, and potential exposure to radiation environments.

Provides engineering support for pharmaceutical and biotech manufacturing operations, including HVAC, utilities, facility systems, troubleshooting, optimization, preventive maintenance, system modifications, validation, equipment qualification, and capital projects. Collaborates with manufacturing, quality, maintenance, facilities, validation, EHS, and external providers to maintain safe, reliable, compliant operations. Supports non-standard shifts, including extended hours and weekends.

Manages capital projects through planning, design, procurement, construction, commissioning, qualification, turnover, and closeout. Responsibilities include defining scope, schedules, budgets, and governance; managing contractors, vendors, engineering firms, and stakeholders; monitoring risks, costs, quality, safety, and regulatory requirements; coordinating procurement and design activities; overseeing change orders and financial forecasting; and providing project performance reporting in regulated manufacturing environments.

Leads capital projects in regulated Life Sciences manufacturing and quality environments. Responsibilities include planning, scheduling, budgeting, risk management, vendor coordination, stakeholder communication, and cross-functional team leadership. Ensures compliance with GMP, FDA, GxP, validation, and internal quality requirements while managing technical platforms and project delivery across IT, automation, quality, engineering, and validation teams. This is a full-time onsite role in Ohio.

Designs, implements, validates, troubleshoots, and maintains integrations among MES, PLC, DCS, SCADA, data historians, and plant IT/OT systems in regulated pharmaceutical manufacturing. Develops ISA-95 architecture and interface specifications, supports EBR and OEE solutions, prepares computerized system validation documentation, ensures regulatory compliance, and provides technical support during implementation, commissioning, qualification, and ongoing operations.

Execute SAP S/4HANA functional, integration, regression, and user acceptance testing; document results, identify and retest defects, validate transactions, support cutover and go-live readiness, and provide post-go-live hypercare. Collaborate with business, functional, and technical teams on issue resolution while maintaining documentation, quality, and change-control requirements. The role is primarily remote but requires Puerto Rico location or onsite availability and U.S. work authorization without sponsorship.

Develop and maintain detailed schedules for pharmaceutical capital projects in a regulated environment. Perform critical path analysis, resource leveling, look-ahead planning, progress tracking, schedule risk analysis, and performance reporting. Coordinate with project teams to resolve dependencies, delays, and sequencing issues while integrating schedules across multiple projects. Ensure planning supports compliant, safe, and timely execution according to GMP and company standards.