Senior Process Engineer at BioPharma Consulting JAD Group

Juncos, , Puerto Rico -

Full Time

Start Date

Immediate

Expiry Date

07 Feb, 26

Salary

0.0

Posted On

09 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmaceutical Manufacturing, Biotechnology Manufacturing, GMP, GLP, Validation Protocols, Technical Report Writing, Problem Solving, Analytical Reasoning, Project Management, Cross-Functional Collaboration, Leadership, Financial Analysis, Cost Estimation, Root Cause Analysis, Process Validation, Data Analysis

Industry

Biotechnology Research

Description

The Senior Process Engineer independently provides and/or directs process characterization, optimization strategies, and troubleshooting support for operations, manufacturing, pilot plant, or capital projects. This role applies advanced and diverse engineering principles to the design and implementation of complex system modifications, process improvements, and capital projects. The engineer develops, organizes, and interprets results to address operational challenges and execute engineering initiatives of significant scope and complexity. Key Responsibilities Lead complex or novel engineering assignments, developing new or improved engineering techniques and procedures. Establish engineering policies and procedures impacting multiple departments or organizational units. Supervise, coordinate, and review work of a small team of engineers, associates, or technicians. Apply advanced engineering methods within and beyond discipline expertise to address cross-functional challenges. Serve as a peer-recognized technical specialist in at least one engineering discipline, determining methodologies and technical approaches. Plan, design, and conduct engineering projects utilizing mature technical knowledge and best practices. Develop creative, data-driven technical solutions to complex process or system issues. Collaborate with research, manufacturing, process development, utilities, facilities, quality, and validation teams to define system requirements and recommend large-scale facility modifications. Partner with project managers to deliver engineering projects within schedule, cost, and quality constraints. Coordinate and oversee the work of consultants, architects, and external engineering firms. Develop and manage departmental or project budgets encompassing multiple engineering disciplines. Competencies & Skills Strong working knowledge of pharmaceutical or biotechnology manufacturing processes. Familiarity with GMP, GLP, validation protocols, and documentation practices in a regulated environment. Proficiency in applying engineering science to production systems and solving routine to complex technical problems. Demonstrated ability in: Technical report and validation protocol writing. Problem solving and analytical reasoning. Verbal and written communication. Equipment-specific technical expertise. Project management, scheduling, and follow-up. Cross-functional collaboration and facilitation. Leadership, negotiation, and vendor/contractor management. Financial analysis and cost estimation. Education & Experience Doctorate in Engineering, or Master’s Degree in Engineering with 2+ years of engineering experience, or Bachelor’s Degree in Engineering with 4+ years of engineering experience. Preferred Qualifications Experience in biotechnology or pharmaceutical manufacturing, particularly downstream processing. Strong background in SOP management, electronic batch records (eBRs), and change control systems. Proven ability to author, review, and approve controlled documents in compliance with GMP standards. Experience supporting new product introductions and major capital or process improvement projects. Skilled in performing root cause analysis (RCA), developing CAPAs, and monitoring effectiveness. Familiarity with process validation, cleaning validation, and process performance monitoring. Experience with SAP, MES (PAS-X), Application Lifecycle Management (ALM) systems, and data analysis tools such as Spotfire or Enterprise Data Lake. Knowledge of SAP-MES integration, BOM configuration, and troubleshooting IDoc communication issues. Strong project management and organizational skills with the ability to handle multiple priorities and lead cross-functional initiatives. Administrative Shift 10-month contract

Responsibilities

The Senior Process Engineer leads complex engineering assignments and develops new engineering techniques. They collaborate with various teams to define system requirements and recommend modifications for large-scale facilities.