Sr. Engineer 35771

Inteldot; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Inteldot is seeking an Administrative Shift engineer to lead complex process optimization and troubleshooting in pharma manufacturing environments. You will apply advanced engineering principles to design and implement major system modifications and capital projects.

The role involves developing and presenting results, coordinating cross-functional teams, and advancing packaging and product quality through rigorous testing and documentation.

Qualifications

• General packaging/engineering experience in final product manufacturing within the Pharma/Biotech Industry.
• Excellent understanding of GMP and GDP.
• Strong knowledge of materials used in pharmaceutical packaging (bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate).
• Familiar with distribution testing per ASTM D4169 and ISO, TAPPI, USP and EP testing standards.
• Strong interpersonal, project management, problem solving and communication skills.
• Ability to work in teams and adapt to a continuously evolving environment.
• Ability to write test protocols, perform evaluations and testing to support reports for materials and packaging components.

Responsibilities

• Complete complex or novel assignments requiring development of new engineering techniques and procedures.
• Develop policies and procedures that affect multiple units.
• Coordinate and review work of a small staff of engineers, associates or technicians.
• Employ advanced engineering techniques within area of expertise.
• Serve as a peer-recognized engineering technology specialist in at least one area.
• Develop technical solutions to complex problems requiring ingenuity.
• Collaborate with research, manufacturing, process development, utilities, facilities, QA and validation.
• Work with project managers to complete design/engineering projects on schedule and budget.
• Coordinate consultants, architects and engineering firms on standard design documents.
• Develop departmental budgets for the project scope.

Skills

GMP/GDP knowledge

Packaging materials know-how

Project management

Technical problem solving

Team collaboration

Communication skills

Education

Doctorate

Masters + 2 years eng experience

Bachelor’s in engineering + 4 years eng exp

Tools

ASTM D4169

ISO/TAPPI/USP/EP standards

Quality documentation practices

Job description

Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative Shift

Job Description:

Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

Requirements & Qualifications:

• General packaging/engineering experience in final product manufacturing within the Pharma/Biotech Industry.
• Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Strong knowledge of common materials used in pharmaceutical primary and secondary packaging (bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc.).
• Familiar with distribution testing per ASTM D4169 and ASTM, ISO, TAPPI, USP and EP testing standards.
• Strong interpersonal, project management, technical problem solving and communication (written and verbal) skills.
• Ability to work in teams and adapt to a continuously evolving environment.
• Ability and experience writing test protocols, performing technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components.

Responsibilities:

• Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• Develop engineering policies and procedures that affect multiple organizational units.
• Coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
• Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
• Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
• Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
• Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project

Education:

• Doctorate OR Masters + 2 years of Engineering experience OR bachelor’s in engineering + 4 years of Engineering experience.