Job Snapshot
Location:
4555 Riverside Drive
Palm Beach Gardens, FL 33410
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Industry:
Biotechnology
Manufacturing
Job Type:
Engineering
Manufacturing
Experience:
At least 3 year(s)
Contact Information
Description
Summary: Plans, directs, and coordinates manufacturing processes in industrial plant by performing the following duties.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Develops, evaluates, and improves manufacturing methods as it relates to both new product and current product. Confers with planning and design staff concerning product design and tooling to ensure efficient production methods. Conducts root cause analysis investigations.
Optimizes product, process, tooling and/or equipment that meet customer needs, technical design goals and regulatory / quality requirements.
Write procedures and/or work instructions and train applicable personnel on new processimplementation and current process improvements.
Review Document Change Requests (DCR's), Non-conformances (NC’s), and critical maintenance forms for validation and FMECA implications and for approval.
Responsible for implementing corrective and preventative actions (CAPA’s).
Plan, create, and execute validations (IQ/OQ/PQ) and risk analyses (PFMECA’s) in accordance with FDA and ISO harmonized standards. Prepare technical reports and feasibility studies.
Ensure that personal safety equipment is utilized and maintained properly.
Estimate production times and related costs to provide information for management decisions.
Support production departments with troubleshooting and correcting equipment and/or process failures to facilitate production of components.
Assist and provide consultation to outside suppliers including the outside process PFMEA, equipment qualifications and process validations. Represent the company in dealings with vendors and suppliers.
Requirements
Education/Experience:
Bachelor's degree (B. A.) in engineering or related technical field from an accredited four-year college or university and preferably two to seven years applicable experience in an FDA regulated environment or equivalent experience.
Working knowledge of medical device manufacturing system requirements specifically 21 CFR 820 preferred
Minimum 3 – 5 years experience with CNC Lathes and general machining techniques, tooling, tolerancing, etc