Validation Engineer (CSV)

Avante Engineering; Juncos (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

Avante Engineering in Juncos, PR is seeking a CSV Validation Engineer to generate and execute validation protocols and ensure alignment with biopharma regulations. You will develop commissioning and qualification documentation, collaborate with cross-functional teams, and contribute to successful project completion.

The role requires a BS in Engineering, 5+ years in CSV, and fluency in English and Spanish. This in-person position offers growth in a fast-paced bio-pharmaceutical environment with

Qualifications

• Bachelor of Science in Engineering or equivalent.
• Experience in the Bio/Pharmaceutical industry.
• Proficient in Commissioning & Qualification documentation.
• Familiarity with CSV regulations and guidelines, including cGMP, ISPE GAMP process, 21 CFR Part 11, 21 CFR 211.68, and Data Integrity.
• Strong analytical thinking and problem-solving skills.
• Team-oriented, capable of collaborating with technical experts, design teams, and other departments.
• Quality and results-oriented mindset.
• 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.

Responsibilities

• Generate and execute validation documents, including protocol creation and testing within the bio-pharmaceutical industry.
• Create and seek approval 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.

Skills

Analytical thinking

Team collaboration

Quality mindset

Communication skills (English &Spanish

Education

Bachelor's degree in Engineering

Job description

Responsibilities

• Generate and execute validation documents, including protocol creation and testing within the bio-pharmaceutical industry.
• Create and seek approval 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 of Science in Engineering or equivalent
• Experience in the Bio/Pharmaceutical industry.
• Proficient in Commissioning & Qualification documentation.
• Familiarity with CSV regulations and guidelines, including cGMP, ISPE GAMP process, 21 CFR Part 11, 21 CFR 211.68, and Data Integrity.
• Strong analytical thinking and problem-solving skills.
• Team-oriented, capable of collaborating with technical experts, design teams, and other departments.
• Quality and results-oriented mindset.
• 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

• Computer Systems Validation (CSV): 5 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