Senior Packaging Engineer – Primary Packaging

MG STAFFING GROUP•Gurabo, PR

1d•Onsite

About The Position

We are seeking a highly experienced Primary Container Technical Owner with extensive expertise in primary packaging materials, packaging processes, and technical project support within a regulated pharmaceutical or medical device environment. The ideal candidate will be able to work independently, integrate quickly into an existing project team, and provide immediate technical leadership.

Requirements

Bachelor's degree Completed.
Minimum of 5 years of relevant experience in Packaging Engineering, primary packaging, or a related technical function within a regulated industry.
Strong expertise in primary packaging materials and primary packaging processes.
Experience within the pharmaceutical, biotechnology, medical device, or other highly regulated industry.
Demonstrated experience supporting packaging operations, engineering batches, line trials, and/or process validation.
Experience conducting or supporting quality investigations, Root Cause Analysis, CAPA, and change controls.
Experience developing, reviewing, or managing material specifications and supplier requirements.
Strong understanding of GMP and regulated manufacturing environments.
Ability to independently perform technical assessments and make risk-based recommendations.
Strong analytical, problem-solving, technical writing, and communication skills.
Ability to collaborate effectively with global and cross-functional teams.
Ability to quickly integrate into an established project team and provide immediate technical support.

Nice To Haves

Previous experience serving as a Technical Owner, Packaging SME, Packaging Engineer, or similar technical role.
Experience with site-to-site product or packaging transfers.
Experience evaluating bulk tablet handling and finished product packaging operations.
Strong knowledge of packaging material specifications, supplier management, and packaging-related quality requirements.
Experience supporting pharmaceutical solid oral dosage products is highly desirable.
Located in Puerto Rico, preferably near Gurabo and/or Guaynabo.
Availability for on-site collaboration as required.

Responsibilities

Perform technical assessments and comparisons between sending and receiving manufacturing sites.
Evaluate bulk tablet handling processes and finished product packaging operations.
Support engineering batches, packaging line trials, and process validation activities.
Lead and support quality investigations, including: Root Cause Analysis (RCA), Product impact assessments, Corrective and Preventive Actions (CAPA).
Review change controls and evaluate associated risks, impacts, and required project deliverables.
Conduct technical evaluations to determine potential impacts on Product quality, Regulatory compliance, Product stability, Supply continuity.
Develop, review, and maintain primary packaging material specifications.
Resolve technical discrepancies between supplier specifications and company requirements.
Collaborate with global cross-functional teams, suppliers, manufacturing, engineering, quality, and project stakeholders.
Provide technical leadership and additional project support to achieve business and project objectives.