Senior Process Engineer

Katalyst CRO; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO seeks a Senior Process Engineer to provide technical support for Process Performance Qualifications. The role requires strong understanding of biopharmaceutical operations and significant experience in executing assessments and reporting on operational readiness. Candidates should possess a Bachelor's degree in engineering and have advanced technical capabilities.

Qualifications

• 6 to 10 years of role-specific experience required.
• Advanced knowledge of pFMEAs and PPQs.
• Comfortable with production module environments.

Responsibilities

• Provide technical support for executing Process Performance Qualifications.
• Develop and execute operational readiness assessments.
• Identify and report on operational gaps and risks.

Skills

Technical support

Process Performance Qualifications

Operational readiness assessment

Root cause analysis

Biopharmaceutical operations

Engineering drawings knowledge

Microsoft Project

Education

Bachelor's degree in engineering

Tools

MS Office

Job description

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Responsibilities

• This role is responsible for providing technical support regarding the execution of 4 Process Performance Qualifications (PPQ) by visiting the tech transfer receiving sites and evaluating the current state of operational readiness through the execution of pFMEA for each site.
• Develop and execute current state operational readiness assessment pFMEAs.
• Report findings with recommendations and escalate critical risks/gaps identified timely.
• Support resolution of identified gaps, identifying root causes and defining corrective/preventive actions with equipment, processes, and automated systems.
• Possess demonstrated technical skills and knowledge with biopharmaceutical operations, specifically Monoclonal Antibody (Manufacturing).
• Possess understanding of engineering drawings, SOPs, vendor documentation, and other technical documentation.
• Efficiently and effectively manage assigned projects and initiatives.
• Assist Senior and Principal Engineers on more complex projects/initiatives as required.

Requirements

• Bachelor's degree in engineering or equivalent field.
• 6 to 10 years of role-specific experience required.
• Advanced experience executing pFMEAs, PPQs, and assessing and reporting on operational readiness.
• Ability to assess and report on process validation activities involving cross-functional teams including Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
• Comfortable walking through all areas of the production module (CNC space, ISO classified rooms, grey space).
• Knowledge of product flow through various production areas.
• Strong understanding of process fundamentals and qualification/validation requirements for small molecule chemical synthesis, monoclonal antibody or protein biomanufacturing, cell therapy, regenerative medicine, sterile drug product fill/finish, analytical QC laboratories, computer systems, and packaging.
• Ability to interact directly and communicate concisely with senior management.
• Advanced Microsoft Project capabilities.
• Familiar with regulatory audit processes and capable of assessing provided supporting documents.
• Proficient in computer skills and MS Office applications.
• This role involves traveling to various sites, with some overseas travel required.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Management and Manufacturing
• Industries: Civil Engineering

This job is active and accepting applications.