Engineer (34538)

Inteldot has over 14 years in the life science industry with allocations across Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Non-standard Shift (Available to work: AM and PM 2/3/2 days shift)

Job Description:

Under general supervision, this role you will provide technical engineering support to continuous daily operations by performing troubleshooting activities, process optimization strategies, upgrades, replacements, and modifications to the process or equipment in the manufacturing operations. Ensure that all operations are accomplished in a compliant manner consistent with current corporate policies, industry standards, and applicable regulatory requirements.

Requirements:

• Experience with equipment and/or process troubleshooting in a regulated environment.
• Knowledge of pharmaceutical/biotech processes and GMP production operations.
• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Under general supervision will evaluate, select and apply standard engineering techniques, basic principles and procedures.
• Actively involved in daily operations when required to meet schedules or to resolve issues.
• Routinely supervise manufacturing processes for performance indicators and operations.
• Suggest problem resolution and provide troubleshooting mentorship.
• Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for process and/or system modifications.
• Support the execution of manufacturing/quality systems such as deviations, equipment qualification and/or process validation, procedures, training, and new product introductions.
• Ability to interpret and apply GLPs and GMPs.
• Comprehensive understanding of validation protocol execution requirements.
  

Education:

• Master degree or Bachelor degree in Engineering & 2 years of Engineering experience (Mechanical, Electrical and/or Chemical Engineering)