CQV Process Engineer (Life Sciences)

$80,000 - $110,000/Yr

Jacobs Engineering Group - Indianapolis, IN

Full-time - Mid Level

Indianapolis, IN

Professional, Scientific, and Technical Services

About the position

As a Commissioning, Qualification, and Validation (CQV) Process Engineer at Jacobs, you will play a pivotal role in providing CQV services to clients within the Life Sciences Industry. This position offers a unique opportunity to work with a Global Engineering Firm, supporting clients who manufacture life-changing products. Your responsibilities will encompass the development and execution of CQV documentation across a diverse range of equipment, facilities, utilities, components, products, and systems for clients in biotechnology, pharmaceuticals, medical devices, gene therapy, and cell therapy manufacturing. You will be involved in projects that include state-of-the-art pharmaceutical facilities, ensuring that these facilities operate in compliance with Good Manufacturing Practices (GMP). In this role, you will be accountable for delivering CQV process support to clients consistently, adhering to industry best practices. Your tasks will include developing CQV planning documents to manage projects effectively, generating and executing CQV protocols while employing Good Documentation Practices (GDPs), and investigating and resolving any protocol exceptions or discrepancies. You will also be responsible for creating technical reports and CQV summary reports, safely starting up equipment, and performing risk and impact assessments. Additionally, you will read and verify facility and equipment drawings, develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation. Your role will also involve participating in integrated delivery (EPCMV) project teams to deliver facility and process solutions, leveraging your engineering knowledge and experience with manufacturing equipment, process equipment, HVAC utilities, instrumentation, controls, and automation to support clients and troubleshoot processes. You will lead tech transfer projects for clients, ensuring that all processes are executed efficiently and effectively. This position requires a collaborative spirit, strong organizational skills, and a commitment to making a significant impact in the Life Sciences sector.

Responsibilities

• Provide CQV process support to clients manufacturing GMP products.
• Develop CQV planning documents to manage CQV projects.
• Generate and execute CQV protocols using Good Documentation Practices (GDPs).
• Investigate and resolve protocol exceptions or discrepancies.
• Develop technical reports and CQV summary reports.
• Start up equipment in a safe and effective manner.
• Perform risk assessments and impact assessments.
• Read and verify facility and equipment drawings (e.g., P&IDs, AF&IDs).
• Develop Standard Operating Procedures (SOPs) and process workflows.
• Create Validation Master Plans and User Requirement Specifications.
• Participate on integrated delivery (EPCMV) project teams.
• Lead tech transfer projects for clients.

Requirements

• Bachelor's degree in Chemical, Mechanical or Electrical Engineering or equivalent experience.
• At least 2 years of CQV process engineering experience in the Life Sciences industry.
• Understanding of Good Manufacturing Practices (GMPs).
• Strong technical writing skills.
• Proficient with Microsoft Office - Word, Excel, PowerPoint, Project.
• Flexibility and willingness to travel and work at various clients' locations.
• Ability to work well with diverse, multi-disciplined groups.
• Effective communication skills with management and project team members.
• Ability to negotiate compromises with project team members.
• Ability to listen and respect team members' ideas and opinions.

Nice-to-haves

• Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations.
• Knowledge of ISPE Baseline Guide 5 Commissioning and Qualification.
• Knowledge of ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems.
• Knowledge of ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
• Knowledge of ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011.
• Knowledge of ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011.
• Six Sigma Certification.

Benefits

• Medical insurance coverage.
• Dental insurance coverage.
• Vision insurance coverage.
• Basic life insurance.
• 401(k) plan with company stock purchase option.
• Unlimited Personalized Paid Time Off (PPTO) policy for full-time salaried/exempt employees.
• Seven paid holidays and one floating holiday.
• Caregiver leave.
• Potential for merit increases and performance discretionary bonuses.