Process Engineer Jobs

About The Position

Requirements

• Bachelor’s degree in an Engineering or Science discipline.
• At least 7 years of experience in pharmaceutical or biotechnology process engineering, manufacturing science and technology, or technical operations, with demonstrated expertise in protein purification.
• Technical experience with chromatography, depth filtration, ultrafiltration/diafiltration, virus inactivation, virus filtration/nanofiltration, column packing, filter integrity testing, and single-use processing systems.
• Experience owning or technically leading equipment and process systems through design, vendor execution, FAT/SAT, commissioning, qualification, process validation, operational handover, and lifecycle support.
• Experience developing and reviewing GxP and engineering deliverables such as user requirements, technical specifications, design documentation, system risk assessments, equipment packages, design qualification, requirements traceability, validation and technology-transfer documentation, and turnover packages.
• Experience with hygienic process equipment and piping design in accordance with ASME BPE, ISO 2037, ISO 2852, and applicable site engineering standards, including cleanability, drainability, dead-leg control, CIP/SIP, materials of construction, automation interfaces, maintainability, and operator-centered design.
• Direct experience in regulated environments, including cGMP and applicable safety and environmental requirements.
• Demonstrated ability to resolve complex technical issues, assess risk, manage deviations/CAPAs/change controls, and communicate recommendations to technical and nontechnical stakeholders.
• Experience working in cross-functional, multicultural, and international project teams and coordinating A/E firms, equipment vendors, and internal functions.
• Ability and willingness to travel domestically and internationally as required; travel is estimated at 25–30%.

Nice To Haves

• Inspection support experience.

Responsibilities

• Own assigned process and equipment systems across the full lifecycle, from concept and design through commissioning, qualification, process validation, operational handover, routine operation, and continuous improvement.
• Translate process, product, regulatory, operational, maintenance, and safety needs into user requirements, technical specifications, system risk assessments, design criteria, and acceptance requirements.
• Provide technical leadership and documented owner input during process, equipment, piping, automation, facility-interface, constructability, operability, maintainability, contamination-control, and safety reviews.
• Coordinate technical interfaces among internal functions, A/E partners, equipment vendors, integrators, and construction/CQV teams; identify gaps, dependencies, and decisions requiring escalation.
• Plan and support vendor document reviews, FAT, SAT, commissioning, troubleshooting, qualification, punch-list resolution, turnover, and package closeout for assigned systems.
• Own or support GxP and project deliverables, including URS, technical specifications, design documentation, equipment packages, DQ, RTM, validation and technology-transfer strategies, ISA-88/common-language documentation, contamination-control inputs, and engineering turnover packages.
• Serve as the process subject matter expert for deviations, investigations, CAPAs, change controls, regulatory commitments, inspection support, startup issues, and equipment performance concerns.
• Support process characterization, technology transfer, PPQ readiness and execution, continued process verification, and establishment of operating ranges, control strategies, and performance monitoring.
• Ensure systems are ready for sustainable site ownership through procedures, training, spare-parts and maintenance strategies, lifecycle documentation, data and alarm review, and knowledge transfer to Operations, Maintenance, Automation, Quality, and MS&T.
• Manage technical risks, issues, actions, and deliverable status against the project schedule; communicate recommendations, mitigation plans, and decisions through project governance.
• Lead complex capital and process-improvement initiatives, apply risk-based decision making, and identify opportunities to improve safety, compliance, reliability, capacity, yield, cycle time, and cost.
• Represent Process Technology/MS&T in cross-functional and global forums and mentor engineers, specialists, and site personnel in the assigned process area.

Benefits

• The position may include incentive compensation and equity in addition to base salary.
• CSL provides employee benefits; details are available on the company’s benefits webpage.