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Sr Engineer- Process Development (CQV)

Karwell Technologies

Newark, OH

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JOB DETAILS
SKILLS
Biology, Commissioning, Cross-Functional, Documentation Plan, Drug Products, FDA Requirements, GMP (Good Manufacturing Practices), Maintain Compliance, Manufacturing, Manufacturing Operations, Operational Strategy, Operational Support, Process Development, Process Validation, Product Testing, Quality Metrics, Regulations, Regulatory Compliance, Sales Qualification, System Validation, Systems Administration/Management, Validation Documentation, Validation Plan, Writing Skills
LOCATION
Newark, OH
POSTED
30+ days ago
Job Description:
We are seeking a highly skilled Sr. Engineer Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final Drug Product (FDP) manufacturing environment. The role involves leading commissioning, qualification, and validation activities for both new and existing equipment and processes, ensuring compliance with FDA regulations and internal quality standards. The Sr. Engineer will serve as the site's technical expert for automated systems and combination product validation, collaborating closely with Engineering, Quality, and Manufacturing teams.

Roles & Responsibilities:

  • Lead commissioning, qualification, and validation activities for automated and semi-automated combination product equipment and processes.
  • Author, review, and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Maintain and manage Master Validation Plans and related documentation to ensure compliance with GMP and FDA regulations.
  • Serve as the technical SME for automated systems, labeling, and packaging process validation.
  • Collaborate with cross-functional teams (Engineering, Quality, Manufacturing) to ensure robust and validated systems supporting 24/7 production operations.
  • Conduct on-site and off-shift validation activities as needed to support continuous manufacturing operations.
  • Identify process gaps and recommend improvements to optimize validation and operational efficiency.
  • Support regulatory audits and inspections by providing accurate and complete validation documentation.

Requirements:

  • Bachelor's or Master's degree in Engineering, Life Sciences, or related technical field.
  • Proven experience in Commissioning, Qualification, and Validation (CQV) within a GMP-regulated manufacturing environment.
  • Hands-on experience with automated and semi-automated equipment, labeling, and packaging operations.
  • Strong knowledge of FDA regulations, GMP standards, and internal quality systems.
  • Experience with validation documentation including Master Validation Plans, IQ/OQ/PQ protocols, and reports.
  • Familiarity with Kneat software is a plus.
  • Ability to work flexible schedules, including on-site and off-shift validation activities.

About the Company

K

Karwell Technologies

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