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Process Engineer

Lab Support, A Division Of On Assignment

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Location: Irvine, CA Posted Date: 5/2/2013 Position Type: Full time Job Code: CM 0003 Required Education: High school or equivalent

Description

World renowned Pharmaceutical Company is seeking a Process Engineer

Summary

This position leads, champions, assesses process improvement initiatives in organizations that can have regional or global focus in a variety of product or service settings. The Process Engineer ensures that proposed engineering changes don’t negatively impact currently approved processes, also monitors regulatory compliance, customer/supplier relations, and deploys initiatives when requested. The Process Engineer manages projects, and recommends solutions to support critical systems . Assists the Senior Manager, Quality in analyzing situations, determining and evaluating risk, and employs knowledge management tools and techniques in resolving organizational challenges. This position will be responsible for reviewing and approving the validation of products/processes, and specifically critical changes of equipment, utility systems, and facility.

Duties and Responsibilities

·Review / analyze data and initiate problem solving, corrective and preventive actions to resolve issue. Drive closure of issues with responsible individuals and departments.

·Provides and direct solutions on a multitude of issues such as approval of SOPs for critical changes, approval of equipment/facility validations or qualifications, provides project support and resolve quality issues. Leads as a Quality representative the re-commissioning of the plant facilities and critical utilities.

·Develop effective communication skills to motivate personnel to meet timelines and quality expectations while maintaining a state of compliance.

·Recommends manufacturing improvement initiatives and communicates results and goals to the Senior Manager, Quality.

·Ensures that metrics are met on regular basis

·A participant during inspections/audits  by Regulatory agencies and Contract Manufacturing customers.

·Represent the Senior Manager at meetings or emergency situations.  

·Provides support to the Senior Manager, Quality in the evaluation of critical changes and review/approval of validations, qualifications, and pilot studies to ensure all regulatory requirements have been met and allow the timely release and delivery of products.

·Provides leadership and communicates metrics regarding Quality Engineering and goals to Senior Manager or upper management. Effectively communicates to other department personnel, as well as outside customers, regarding any issues or resolutions.

Requirements

·Bachelors degree (e.g., any field related to Engineering, Pharmacy, etc.) or equivalent related industry experience

·A minimum of three years of experience must be in a decision-making position. “Decision-making” is defined as the authority to define, execute, or control projects/processes and to be responsible for the outcome. This may or may not include management or supervisory positions

·cGMP Manufacturing experience

·Management experience

·Experience in project management and validation

·Experience with pharmaceutical equipment, facilities, lab instrumentation, etc.

·Excellent interpersonal and communications skills required

·Strong organizational and technical writing skills required
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