Product Development Engineer III - APPLICANTS MUST BE FLUENT IN ENGLISH AND SPAN
Planet Pharma, El Paso, TX, United States
APPLICANTS MUST BE FLUENT IN ENGLISH AND SPANISH
Term
12-Month Contract (Potential for extension)
Pay
$40.54/hour W2
The Opportunity
This is a hands‑on, execution‑focused role where you will take technical ownership of validating new equipment and processes for new product development. If you thrive in regulated environments (Medical Device/Pharma) and enjoy the “doing” side of engineering—from technical writing to floor execution—this is the role for you.
Day‑to‑Day Impact
Validation Leadership:
Lead the development and execution of IQ/OQ/PQ protocols and reports.
Equipment Oversight:
Coordinate with suppliers for the manufacturing, delivery, and installation of custom equipment and tooling.
Documentation:
Generate and approve SOPs, manufacturing procedures, and quality docs (batch records).
Process Optimization:
Develop Test Method Validations, Gage R&R, and execute Process Characterizations (DOE).
Compliance:
Ensure all work meets strict cGMP, ISO, and Quality Standards.
Must‑Haves
Experience:
4+ years of heavy validation experience within the Medical Device or Pharmaceutical industries (other highly regulated industries considered with strong IQ/OQ/PQ background).
Technical Expertise:
Strong grasp of Risk Management (FMEA) and Geometric Dimensioning and Tolerancing (GD&T).
Documentation:
Proven ability in technical writing for SOPs and validation protocols.
Education:
Completed Bachelor’s Degree in Engineering.
Soft Skills:
A “self‑driver” mentality—you don’t wait for instructions; you identify what needs to be done and execute.
Software:
Proficiency in Minitab, AutoCAD, or SolidWorks.
Certifications:
Lean/Six Sigma, PMP, or Engineering Board Certification (EIT/PE).
Project Management:
Experience with MS Project and capital project justification.
Interview Process
We are looking to move quickly. Candidates should be prepared for a single‑round onsite interview before a hiring decision is made.
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Term
12-Month Contract (Potential for extension)
Pay
$40.54/hour W2
The Opportunity
This is a hands‑on, execution‑focused role where you will take technical ownership of validating new equipment and processes for new product development. If you thrive in regulated environments (Medical Device/Pharma) and enjoy the “doing” side of engineering—from technical writing to floor execution—this is the role for you.
Day‑to‑Day Impact
Validation Leadership:
Lead the development and execution of IQ/OQ/PQ protocols and reports.
Equipment Oversight:
Coordinate with suppliers for the manufacturing, delivery, and installation of custom equipment and tooling.
Documentation:
Generate and approve SOPs, manufacturing procedures, and quality docs (batch records).
Process Optimization:
Develop Test Method Validations, Gage R&R, and execute Process Characterizations (DOE).
Compliance:
Ensure all work meets strict cGMP, ISO, and Quality Standards.
Must‑Haves
Experience:
4+ years of heavy validation experience within the Medical Device or Pharmaceutical industries (other highly regulated industries considered with strong IQ/OQ/PQ background).
Technical Expertise:
Strong grasp of Risk Management (FMEA) and Geometric Dimensioning and Tolerancing (GD&T).
Documentation:
Proven ability in technical writing for SOPs and validation protocols.
Education:
Completed Bachelor’s Degree in Engineering.
Soft Skills:
A “self‑driver” mentality—you don’t wait for instructions; you identify what needs to be done and execute.
Software:
Proficiency in Minitab, AutoCAD, or SolidWorks.
Certifications:
Lean/Six Sigma, PMP, or Engineering Board Certification (EIT/PE).
Project Management:
Experience with MS Project and capital project justification.
Interview Process
We are looking to move quickly. Candidates should be prepared for a single‑round onsite interview before a hiring decision is made.
#J-18808-Ljbffr