Sr. Engineer 35771

Inteldot; Puerto Rico; On-site; USD 110,000 - 150,000; Full time

Job summary

Inteldot is seeking an experienced engineer for an Administrative Shift in Puerto Rico/United States to advance process optimization and packaging improvements in pharma operations.

You will develop and implement major system modifications, analyze results, and present findings to support capital projects. Strong GMP/GDP knowledge, packaging materials expertise, and leadership skills are required.

Qualifications

• Bachelor’s degree in engineering with substantial pharma/biotech packaging experience required.
• Experience writing test protocols and performance evaluations for materials used in packaging.
• Strong GMP/GDP knowledge and documentation practices.
• Ability to lead small teams of engineers, associates and technicians.
• Excellent written and verbal communication for complex engineering issues.

Responsibilities

• Develops and implements major system modifications in operations, manufacturing, pilot plant or capital projects.
• Applies advanced engineering principles to design and implement engineering solutions.
• Develops results interpretations for operational issues or engineering projects of significant scope.
• Coordinates and reviews work of engineers and technicians on projects.
• Develops engineering policies and procedures affecting multiple units.
• Collaborates with QA, validation, and facilities to define requirements for modifications.

Skills

GMP/GDP

Pharma Packaging

Packaging Materials

Testing Standards

Teamwork

Project Management

Communication

Education

Doctorate

Masters + 2 years experience

Bachelor's in Engineering + 4 years

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.