Biopharma Commissioning & Qualification Engineer

Avante Engineering LLC.

Juncos (PR)

On-site

USD 65,000 - 90,000

Full time

14 days+

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Job summary

Avante Engineering LLC. is seeking a Commissioning & Qualification Scientist/Engineer to develop and execute software and equipment qualification processes for bio/pharmaceutical projects in Juncos, PR.

The role emphasizes ensuring quality through comprehensive validation activities and collaboration with multiple departments. The ideal candidate holds a Bachelor’s degree in Engineering or Life Sciences and has 3+ years of CQ experience, with strong analytical and bilingual English/Spanish

Qualifications

Bachelor’s degree in Engineering, Life Sciences, or related field.
3 years of Commissioning & Qualification experience in bio/pharma sectors.
Strong analytical thinking and problem-solving capabilities.
Team-oriented with ability to collaborate across departments.
Proficient English and Spanish communication, both written and verbal.

Responsibilities

Generate and execute validation documents, including protocol creation and testing.
Prepare and approve qualification documents (C&Q Plan, URS, Design Specs, RTM, Summary Reports).
Revise design specifications to meet new requirements.
Develop qualification protocols for manufacturing equipment, utilities, and facilities.
Prepare comprehensive summary reports based on validation results and procedures.