Sr. Engineer

FITS LLC; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a seasoned Manufacturing/Packaging Engineer to lead complex engineering work in a regulated environment. The role requires a Bachelor's degree in Engineering with 4+ years in packaging process and hands-on experience with deviations, CAPAs, change controls, risk assessments, and post-FDA commitments.

Bilingual English/Spanish and project management skills are essential. You will develop engineering policies, supervise a small team, apply advanced techniques,

Qualifications

• Bachelor's degree in Engineering with 4 years of packaging process experience in regulated industry.
• Bilingual in English and Spanish.
• Project management skills in engineering contexts.
• Experience with deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitments.

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.
• Supervise, 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.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• 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.
• 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

Skills

Bilingual (English & Spanish)

Project Management

Packaging Process experience

Education

Bachelor's Degree in Engineering with four (4) years of Packaging Process experience within the regulated industry

Job description

For Manufacturing services in the Engineeringare.

WHAT MAKES YOU A FIT:

THE TECHNICAL PART:

• Bachelor'sDegree in Engineering withfour (4) years of Packaging Process experience within the regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative and according to business needs.
• Experience in:
  • Technical support for deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitments.
  • Assessment of equipment design, functionality, reliability, lifecycle documentation, maintenance strategies.

AS A PIECE OF FITS, YOU WILL:

(The day-to-day on the job)

• 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.
• Supervise, 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.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
• Application of mature engineering knowledge in planning and conducting projects.
• 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.
• 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

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!

Are you the next piece?