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Sr Engineer- Process Development (CQV)

Newark, OH, US • Posted 4 hours ago • Updated 4 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

Process Engineering
Assembly
Management
Regulatory Compliance
Collaboration
Manufacturing Operations
Operational Efficiency
Auditing
Life Sciences
Manufacturing
GMP
Quality Management
Documentation
IQ
OQ
PQ

Summary

Job Summary:

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.
uthor, 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.

Education & Experience:

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 utomated 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.
bility to work flexible schedules, including on-site and off-shift validation activities.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 34b3a5705fa04862ab052068304fcfe7
Posted 4 hours ago

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