Sr. Engineer (Automation/Packaging)

Full Time Contract
Title or Role: Sr. Engineer (Automation/Packaging)
Location: Juncos, Puerto Rico, 100% on-site
Length of Contract: Six (6) months+

Scope of Job
RCM is looking for Packaging Equipment Qualification Sr. Engineers to support the implementation of new packaging lines in the facility.

Position Description:
Provides direct support to the requirement, design, and qualification of packaging equipment as well as the installation/optimization strategies and/or troubleshooting of operational issues in the operations.

Primary Responsibilities

• Provide advanced technical support to automatic packaging equipment and processes as to the installation/qualification and process development of the equipment functionality.
• Support troubleshooting, investigations, root cause analysis related to the packaging area and inspection process.
• Identify and implement initiatives in the packaging processes in order to reduce manufacturing operational costs while maintaining product quality.
• Design / Development of Qualification Protocols.
• Establish Testing Strategies.
• Technical Reports Development.
• Validations, and technical reports- to support Site Acceptance Tests (SATs) executions, document generation and challenge validations strategies.
• Perform risk assessments to support activities.

Qualifications:

• Background in medical devices (preferred) or drug products manufacturing environment.
• Experience in medical devices product assembly packaging is a plus.
• Experience in Change Control Development.
• Inspection/packaging Concepts Knowledge.
• Strong knowledge of cGMPs regulations.
• Good skills writing general documentation in English and using MS Office applications.

Education & Certifications

• BS or higher in Engineering (excluding civil) with at least five years of experience in the life sciences industry.