Process Improvement Engineer/Specialist

Inteldot • Barceloneta, PR

4d

About The Position

The selected candidate will lead process problem-solving activities, ensuring that root causes are identified and that effective corrective and preventive actions are implemented to prevent recurrence. The role is responsible for documenting problem-solving activities and technical assessments for deviations within established target closure timelines. The candidate will be accountable for evaluating deviation trends and recommending actions to drive continuous improvement in support of Operations and Site objectives. This position is also responsible for conducting manufacturing and/or packaging process investigations.

Requirements

• Bachelor’s degree in engineering, sciences or related field.
• 3–6+ years of experience in manufacturing, packaging, process engineering, MS&T, or technical operations within a regulated industry (pharma, biotech, medical devices, or similar).
• Knowledge of Regulations such as cGMP’s and EMEA.
• Demonstrated experience leading or supporting: Deviation investigations, root cause analysis, CAPA Process improvements (yield, cycle time, quality, cost) Change management (PCR, ECR, change controls)
• Hands-on experience with manufacturing and/or packaging processes
• Experience supporting or executing: Process validation / qualification Cleaning validation assessments Technology transfer or new product introduction
• Communicates clearly and concisely in English / Spanish verbally and written.

Nice To Haves

• Master’s degree in engineering or science preferred (not required).

Responsibilities

• Responsible for the identification and implementation of scientific and technological opportunities in manufacturing and/or packaging areas for cost, cycle time and quality improvements.
• Analyzes data, recommends, designs and implements process performance improvements.
• Responsible for continuous process verification activities within the department for in line products (i.e. Risk Assessments, Process Specific Trainings).
• Proactive Process Analysis owner for Operations.
• Executes change requests and qualifications for existing equipment.
• Provides technical support for the validation of new and existing processes, cleaning assessments and experimental trials.
• Provides technical support on new product introduction and product transfer activities, including data gathering and analysis, sampling and validation.
• Accountable in the development of technical training and SOPs.
• Responsible to support Process Change Request process, including performing activities as required by regulatory documentation such as PCR, ECR, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level