Process Engineer (direct hire)
Process Engineer (direct hire)
Kelly
Cleveland, OH
Job ID : 744a4f7142313274525a5a782f77484558413d3d
Job Description :
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting direct hire, permanent opportunity as a Process Engineer for a top fortune 500 company based in Cleveland OH.
Title: Process Engineer
Duration: DIRECT HIRE opportunity!
Location: Cleveland OH
Essential Duties and Responsibilities:
Qualifications:
Education / Experience:
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Michelle Niemira (micn083@kellyservices.com) for immediate consideration.
Title: Process Engineer
Duration: DIRECT HIRE opportunity!
Location: Cleveland OH
Essential Duties and Responsibilities:
- Ensures all process engineering work is in compliance with all Current FDA Requirements, follows Good Manufacturing Practices (cGMP) and International Organization for Standardization (ISO) requirements.
- Ensures the ECR/ECO process is understood and strictly followed where appropriate for all Engineering Changes.
- Responsible for the ongoing effort to evaluate, recommend, and manage the implementation of technical enhancements to improve package functionality, ensure product manufacturability, strengthen manufacturing’s operational capabilities, optimize processing methods, ensure process reproducibility, improve batch yields and reduce process cycle times.
- Audit Compliance: Ensures Projects are compliant and audit ready for outside regulatory agencies and internal audits regarding all Engineering Process changes and appropriate documentation.
- Works closely with the Quality and Regulatory groups to ensure all Engineering and Process Changes are compliant with the client’s Quality Management System.
- Lead and actively participate in the effort to develop and perform Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) documentation and drawings to ensure compliance with current FDA and ISO requirements.
- Work closely with Manufacturing and other Engineering personnel to develop and maintain the required preventative maintenance (PM) plans for all equipment procured or designed and built in house.
- Provides manufacturing department with decision-making information by calculating production, labor and material costs; accurately estimating future requirements.
- Lead or work closely with Manufacturing in the effort to investigate, review and remediate system and/or equipment failures in Manufacturing.
- Effectively lead and execute a project from start to finish. This includes collaborating with multiple departments and disciplines.
- Participates in the site master validation program
- Support of additional areas of process improvement as needed (Equipment, Facilities, Cleaning, Periodic Review & Revalidation, etc.) by authoring, reviewing, and approving documents as well as coordinating timing and resources
- Utilize proven methods for Process and Packaging Optimization and Statistical methods used for Process Validation
- Assist in developing and implementing improved validation policies.
- Collaborate on documents and Interface in meetings with internal customers
- Maintain an “Engineer for Safety” and “Risk Analysis” mentality for all products, component and equipment designs and process implementations.
- Utilize failure analysis process and write final reports as required.
- Remain compliant on all required training for programs to satisfy OSHA, Fire Safety, Hazardous Material handling, and other governmental regulations that affect facility operations.
- Comply with all company policies, practices and procedures.
Qualifications:
- 2-5 years of specific experience in Engineering Process Improvement / Validation team in an FDA regulated environment
- Strong working knowledge of GMP, FDA and ISO requirements
- Proven experience in writing and performing Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) protocols and documents is required
- Recent relevant experience of working closely with Manufacturing on equipment and process optimization initiatives
- Strong verbal and written communication skills with extensive experience presenting complex proposals.
- Highly organized, accurate and detail oriented.
- Ability to manage and lead multiple projects with conflicting priorities
- Strong background in medical device standards and statistical analysis methods and techniques.
- Experience in Computer System / Software Validation; solid understanding of the FDA’s General Guidance Document for software validation is preferred
- Proven experience in utilizing a facility wide Preventative Maintenance Management System for an FDA regulated company
- Ability to think ahead, understand the big picture when planning and executing new processes. Can identify the strategic changes that will have significant impacts
Education / Experience:
- Bachelor’s Degree in Mechanical Engineering, Bio-Medical Engineering or related discipline required.
- 2-7 years of related experience in the medical device or pharmaceutical industry
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Michelle Niemira (micn083@kellyservices.com) for immediate consideration.
Company Details :
Name : Kelly
CEO : Peter Quigley
Headquarter : Troy, MI
Revenue : $5 to $10 billion (USD)
Size : 5001 to 10000 Employees
Type : Company - Public
Primary Industry : HR Consulting
Sector Name : Human Resources & Staffing
Year Founded : 1946
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Details
: Cleveland, OH
: Today
