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.
Requirements
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.
Benefits
- Administrative Shift
- 10-month contract
Top Skills
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results.
Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields.
We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions.
BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
