Commissioning & Qualification Scientist/Engineer

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

Job summary

Avante Engineering in Juncos, PR seeks a Commissioning & Qualification Scientist/Engineer to lead validation activities in Bio/Pharmaceutical environments. You will generate and execute validation documents, develop qualification protocols, and prepare comprehensive reports.

Ideal candidates combine a engineering or life sciences background with hands-on CQ experience, strong collaboration skills, and fluent English and Spanish communication. This in-person role requires relocation to PR.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• Experience in Bio/Pharmaceutical industry.
• Proficient in Commissioning & Qualification documentation.
• Strong analytical thinking and problem-solving skills.
• Team-oriented and able to collaborate with cross-functional teams.
• Excellent English and Spanish written and spoken communication.

Responsibilities

• Generate and execute validation documents, including protocol creation and testing within the bio-pharmaceutical industry.
• Develop qualification protocols for new or modified manufacturing equipment, utilities, and facilities.
• Prepare comprehensive summary reports based on validation and qualification test results.
• Provide support during implementation, collaborating with affected departments and personnel.
• Participate in progress meetings to ensure schedules are maintained and action items are addressed.

Skills

Analytical thinking

Problem-solving

Team collaboration

Documentation skills

Communication skills

Bilingual English/Spanish

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Tools

C&Q documentation

Job description

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.
• Proficient in Commissioning & Qualification documentation.
• 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)
• English (Required)

Ability To Commute

• Juncos, PR 00777 (Required)

Ability To Relocate

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

Work Location:

• In person