Sr. Process Engineer - Drug Product

FITS, LLC; Juncos (PR); On-site; USD 75,000 - 105,000; Full time

Job summary

FITS in Puerto Rico is seeking an experienced Process Engineer to support manufacturing services within the engineering area. The role emphasizes developing new techniques and procedures for a regulated environment and coordinating with cross-functional teams.

The ideal candidate holds a Bachelor's degree in Engineering with four years of process experience, including drug product manufacturing, characterization, and PPQ/validation lifecycles, and has knowledge of AI-enabled tools such as

Qualifications

• Bachelor's Degree in Engineering with four (4) years of Process experience within the regulated industry.
• Shift: Administrative and according to business needs.
• Experience in: Drug Product Manufacturing, Characterization Processes, Process Performance Qualifications and Validations Lifecycle, Working knowledge of AI-enabled or automation tools such as Python, Codex, Power Automate, SQL, or VBA.

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.
• 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

Skills

Process engineering

Drug manufacturing

Validation lifecycle

Automation tools

Python

SQL

Power Automate

VBA

Education

Bachelor's degree in Engineering

Tools

Python

Codex

Power Automate

SQL

VBA

Job description

For Manufacturing services in the Engineering a rea.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree in Engineering withfour (4) years of Process experience within the regulated industry.
• Shift: Administrative and according to business needs.
• Experience in:
  • Drug Product Manufacturing
  • Characterization Processes
  • Process Performance Qualifications and Validations Lifecycle
  • Working knowledge of AI-enabled or automation tools such as Python, Codex, Power Automate, SQL, or VBA.

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!