Scientific Search ยท 2 weeks ago
Senior Process Design/Mechanical Engineer
United States
Full-time
Remote
Senior Level, Lead/Staff
10+ years expScientific Search is a well-established privately owned engineering and design firm seeking a Senior Process Design/Mechanical Engineer to join their pharmaceutical and health-focused engineering team. The role involves leading the design of critical process systems, ensuring compliance with cleanliness and regulatory standards, and collaborating with various teams to solve complex challenges.
Human ResourcesStaffing Agency
Responsibilities
Lead the creation, review, and revision of P&IDs for pharmaceutical process systems
Specify piping materials, fittings, and instrumentation to meet GMP and cleanroom standards
Coordinate with process chemists and validation teams to ensure piping layouts support sterile operations
Design laboratory floor plans, utilities, and aseptic production lines (Grade A/B/C/D environments)
Ensure layouts allow proper workflow, segregation of clean/dirty areas, and ease of maintenance
Collaborate with microbiologists and quality assurance for validation protocols
Specify and size HVAC equipment (AHUs, CRAC units, HEPA filtration) to maintain ISO classifications and pressure differentials
Model airflow patterns and temperature/humidity controls in Revit or comparable CAD software
Coordinate ductwork, diffusers, and exhaust systems with MEP teams to guarantee aseptic conditions
Develop comprehensive Revit models for piping, equipment, and HVAC systems, ensuring clash detection and constructability
Produce clear, annotated construction drawings, isometric sketches, and material take-offs
Maintain organized drawing archives and version control in project management platforms
Serve as the primary technical liaison between clients, architects, QA/QC teams, and construction contractors
Lead design review meetings, present key process concepts, and incorporate stakeholder feedback
Coach junior engineers and drafters, fostering a team environment of continuous learning
Stay current on FDA, EMA, and WHO guidelines related to aseptic manufacturing, cleanroom design, and validation requirements
Integrate industry best practices for risk mitigation, maintaining design integrity for qualification/validation
Support commissioning, qualification, and start-up phases by providing as-built markups, punch lists, and technical troubleshooting
Qualification
Required
Bachelor's or Master's degree in Mechanical Engineering, or a related field (Pharmaceutical Engineering focus preferred)
Minimum 10 years designing process systems for pharmaceutical or biotech facilities
Proven track record with P&ID development, lab design, and aseptic line projects
Hands-on experience specifying and modeling HVAC systems for controlled environments
Expert proficiency in Revit (3D modeling, clash detection, families)
Strong background in AutoCAD or CADWorx for P&ID development
Familiarity with SmartPlant or AVEVA/E3D (bonus)
Proficient in Microsoft Office Suite (Excel, Word, PowerPoint) for reporting and presentations
Thorough understanding of GMP, FDA's 21 CFR Part 11/210/211, ISO 14644, and other cleanroom standards
Experience supporting commissioning and validation activities (IQ/OQ/PQ deliverables)
Exceptional verbal and written communication: able to explain complex technical concepts in a clear, down-to-earth manner
Collaborative mindset: enjoys mentoring junior staff, soliciting feedback, and building cross-disciplinary rapport
Client-facing confidence: comfortable leading meetings, delivering status updates, and addressing tough questions with poise
Company
Scientific Search
Scientific Search is a staffing and recruiting company offering pharmaceutical, engineering, and it recruiting services.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase