Commissioning & Qualification Scientist/Engineer

Avante Engineering LLC.; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

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.

Skills

Analytical thinking

Team collaboration

Verbal & written communication (EN/ES)

Spanish language proficiency

Education

Bachelor's degree in Engineering/Life Sciences

Job description

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We are seeking highly skilled technical professionals capable of providing commissioning and qualification services within the Pharmaceuticals, Biotechnology, and Medical Devices Manufacturing industries.

The Commissioning & Qualification Scientist/Engineer will play a crucial role in the development and execution of software and equipment qualification processes.

Responsibilities and Duties:

• Generate and execute validation documents, including protocol creation and testing within the bio-pharmaceutical industry.
• Generate/Approve for validation documents such as C&Q Plan, URS, Design Specs, Requirements Traceability Matrix, and Summary Reports tailored for the Biopharmaceutical industry.
• Revise Design Specifications as necessary to align with new design requirements.
• Develop qualification protocols for new or modified manufacturing equipment, utilities, and facilities.
• Prepare comprehensive summary reports based on the results of validation and qualification tests, as well as reviews of procedures and protocols.
• Provide support during implementation, collaborating with affected departments and personnel.
• Actively participate in progress meetings to ensure affected departments are kept up to date with project achievements and communicate any action items necessary to maintain project schedules.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field
• Experience in the Bio/Pharmaceutical industry.
• Strong analytical thinking and problem-solving skills.
• Team-oriented, capable of collaborating with technical experts, design teams, and other departments.
• Computer literate with excellent verbal and written communication skills in both English and Spanish.
• Exceptional attention to detail, with the ability to independently proof work for accuracy.

Job Type:

• Full-time

Education:

• Bachelor’s (Required)

Experience:

• Commissioning & Qualification: 3 years (Required)

Language:

• Spanish (Required)

Ability to Commute:

Ability to Relocate:

• Juncos, PR 00777: Relocate before starting work (Required)

Work Location:

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