Senior Process Engineer

Precis Engineering, Inc.; Ambler (Montgomery County); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Competitive compensation package

Collaborative work environment

Best Place to Work recognition

Job summary

Precis Engineering, Inc. in Ambler, PA is seeking a Senior Process Engineer to lead design, startup, qualification, and optimization of manufacturing processes for pharmaceutical, biotech, and related industries. This role requires extensive experience in process design, equipment integration, and capital projects.

You will drive process safety, compliance, and operations support while mentoring teams and delivering measurable business value through engineering excellence.

Qualifications

• Bachelor’s degree in chemical engineering or related field.
• Minimum 10–15 years of progressive process engineering experience in pharma/biotech environments.
• Strong knowledge of process design, safety, and regulatory compliance.
• Experience leading capital projects from concept through commissioning and startup.
• PE registration is a plus.

Responsibilities

• Lead process design for manufacturing facilities and capital projects from concept to detailed design.
• Develop PFDs, P&IDs, equipment layouts, mass/energy balances, and specs.
• Provide startup, qualification, troubleshooting, and operations support.
• Lead HAZOPs, risk assessments, and safety evaluations to ensure compliance.
• Mentor junior engineers and drive standardized specifications and templates.
• Coordinate with vendors, operations, and stakeholders; manage budgets and schedules.
• Support GMP/regulatory submissions and environmental/permit activities.

Skills

Technical leadership

Project management

Manufacturing optimization

Team mentorship

Process design

HAZOP

Communication

Education

Bachelor’s degree in chemical engineering

Professional Engineer (PE) registration

Job description

Precis Engineering + Architecture (Precis) is a 150+ person consulting firm with offices in Ambler, Pa., and Cary, N.C., offering comprehensive design services. Precis has been repeatedly recognized as a Best Place to Work by the Philadelphia Business Journal.

Position Overview:

The Senior Process Engineer supports the Ambler, Pa., office and will provide technical leadership for the design, optimization, startup, troubleshooting, and qualification of manufacturing process and capital projects within the pharmaceutical, biotechnology, chemical, and related process industries. The successful candidate will serve as a subject matter expert, leading multidisciplinary teams through all phases of project execution while ensuring compliance with safety, quality, regulatory, and operational requirements.

This role requires a seasoned engineering professional with extensive experience in process design, equipment integration, facility expansion, process safety, commissioning, qualification, and operational support.

The Senior Process Engineer will drive improvements in manufacturing safety, quality, reliability, and productivity while supporting strategic capital investment initiatives. This position serves as a key technical leader responsible for delivering innovative, practical engineering solutions that improve operational performance and generate measurable business value.

Responsibilities:

Process Engineering & Design

• Lead process design activities for manufacturing facilities and capital projects, including conceptual, preliminary, and detailed design.
• Develop and review process flow diagrams (PFDs), piping & instrumentation diagrams (P&IDs), equipment layouts, process calculations, mass and energy balances, and engineering specifications.
• Perform equipment sizing, utility assessments, hydraulic analyses, and process modeling.
• Develop basis of design documents, engineering studies, and technical recommendations.
• Support facility retrofits, capacity expansions, process improvements, and new product introductions.

Capital Project Execution

• Lead and support capital projects from concept through startup and turnover.
• Develop project scopes, schedules, cost estimates, and resource plans.
• Manage project budgets and monitor project performance throughout the project lifecycle.
• Coordinate activities among engineering disciplines, vendors, contractors, operations personnel, and stakeholders.
• Participate in design reviews, constructability assessments, FATs, SATs, commissioning, and startup activities.

Process Safety & Compliance

• Lead and participate in HAZOP, process hazard analyses, risk assessments, FMEA reviews, and safety evaluations.
• Develop and maintain engineering standards, design guidelines, and technical specifications.
• Ensure compliance with applicable regulatory requirements, GMP standards, environmental regulations, and company engineering practices.
• Support environmental permitting and regulatory submissions as required.

Operations Support

• Provide troubleshooting expertise for manufacturing processes and utility systems.
• Identify process bottlenecks and implement improvements to enhance safety, reliability, throughput, and product quality.
• Support maintenance and operations teams to resolve complex technical issues.
• Lead root cause investigations and implement corrective actions.

Pharmaceutical & Biotech Support

• Support equipment and facility qualification activities including IQ/OQ/PQ protocol development and execution.
• Assist with validation strategies and implementation for manufacturing and utility systems.
• Provide expertise in pharmaceutical processing equipment, solid dosage manufacturing, API production, biologics, vaccine operations, and clean utility systems.

Technical Leadership

• Serve as a subject matter expert (SME) for process equipment and manufacturing systems.
• Mentor junior engineers and provide technical guidance across project teams.
• Develop standardized specifications, best practices, and engineering templates.
• Lead vendor technical reviews and equipment procurement activities.
• Process design and optimization
• Capital project management
• Process safety management
• Equipment specification and procurement
• Manufacturing troubleshooting
• Commissioning and startup
• Validation and qualification
• Technical leadership
• Budgeting and cost control
• Cross-functional collaboration

Qualifications:

• Bachelor’s degree in chemical engineering or a related engineering discipline; advanced degree a plus.
• Professional Engineer (PE) registration a plus.
• Minimum 10–15 years of progressive process engineering experience in pharmaceutical, biotechnology, specialty chemical, API, vaccine, or industrial manufacturing environments.
• Knowledge of oral solid dosage, API, biologics, vaccine, chemical processing, or batch manufacturing operations a plus.
• Familiarity with clean utilities, CIP/SIP systems, refrigeration systems, and process automation a plus.
• Demonstrated experience leading capital projects from concept through commissioning and startup.
• Experience supporting equipment qualification and process validation programs a plus.
• Experience with GMP-regulated manufacturing environments a plus.
• Strong knowledge of process design principles, equipment specification, process safety, and regulatory compliance.
• Experience with HAZOPs, risk assessments, and engineering change management.
• Proven ability to troubleshoot complex manufacturing processes and implement sustainable solutions.
• Strong communication, leadership, and project management skills.

Why Join Precis?

• Be part of a collaborative, innovative team that values your ideas and expertise.
• Shape growth for a respected, specialized engineering and architecture firm.
• Enjoy a flexible, supportive work environment and competitive compensation package.

Equal Opportunity Employer:

Precis provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics.