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MANUFACTURING ENGINEER

Zenith LifeScience
South Plainfield, NJ

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Job Details

Full-time
$70,000 - $80,000 a year

Qualifications

ISO standards
Production validation processes
Test validation method

Full Job Description

Department: Product Life cycle Management/Validation

The primary purpose of this position is to evaluate, select and apply standard engineering practices, techniques and procedures while using sound judgment when making adaptations and/or modifications to machinery, test and measurement equipment and/or systems. Ensures company’s internal and external customer expectations are met or exceeded.

Responsibilities:

Plan, develops, and executes process and test method validations (IQ, OQ, PQ, PPQ) in accordance with company and guidelines
Design control systems to coordinate activities and production planning in order to ensure that products meet quality standards
Figure out how to manufacture parts or products, or deliver services, with maximum efficiency
Development and implementation of investigations, protocols and test standards, procedures to maintain required
Follows and develops Quality and Regulatory requirements including Company’s policies, procedures, and appropriate regulatory requirements
Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness using common Company’s engineering tools & templates where available, (Examples include specifications, manufacturing procedures, ECOs, and technical reports or analysis)
Applies and promotes Lean manufacturing techniques to continuously improve cycle times and process flows. Identifies, supports, or directs the execution of improvement efforts to reduce waste in all manufacturing and business processes
Support and Participate in the lean manufacturing cultural change to drive out waste in manufacturing processes
Program data validation checks and listings to identify production discrepancies
Review production schedules, engineering specifications, process flows, and other information to understand methods that are applied and activities that take place in manufacturing and services
The beneficiary will develop a validation master plan which will document a complete list of process validation studies required for product, including the appropriate level of effort and timing of process validation activities
Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness using common Company’s engineering tools & templates where available. (Examples include specifications, manufacturing procedures, ECOs, and technical reports or analysis)
Uses structured problem solving techniques and statistical methods for data driven analysis and decisions to improve production / solve problem
The beneficiary will perform risk assessment and gap analysis of software and use gap analysis to rectify those gapes in requirements

Educational and/or experience requirements:

Bachelor’s or higher degree in Industrial / Pharmaceutical Engineering or related field
Working knowledge of ISO and applicable customer and regulatory standards
Good Understanding of IQ/OQ/PQ/PPQ

Job Type: Full-time

Salary: $70,000.00 to $80,000.00 /year

Please send profile at [email protected] for direct consideration or question.

Posted on 06/11/2022

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Engineer Manufacturing/Design/Test jobs

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