Senior CQV Engineer

Kelly Services; Juncos (PR); Hybrid; USD 51,000 - 73,000; Full time

Benefits offered by this job

Competitive pay

Biweekly direct deposit (W-2)

Paid vacation, sick leave, holidays

Christmas bonus eligibility

Job summary

Senior CQV Engineer role in Juncos, PR, offering a competitive hourly wage of $45.00 and W2 employment, with administrative shift support for 24/7 operations and some remote work possible.

Responsibilities include developing C&Q strategies, leading FAT/SAT activities, IQ/OQ/PQ execution, and ensuring GMP/Regulatory compliance across projects in a biotech environment.

Qualifications

• MS degree in Engineering with 2 years of related experience OR BS in Engineering with 4 years of related experience in pharma/biotech manufacturing.
• Experience leading C&Q strategies in GMP environments.
• Strong expertise in FAT, SAT, startup, field commissioning, and IQ/OQ/PQ execution.
• Knowledge of GMP, FDA/EMA regulations, ALCOA+ data integrity, and change controls.

Responsibilities

• Develop and implement the overall C&Q strategy aligned with project and regulatory requirements.
• Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning.
• Author, review, and approve qualification protocols (IQ, OQ, PQ).
• Documentation & compliance to GMP/FDA/EMA standards; manage risk assessments and CAPA.
• Collaborate with Engineering, Validation, QA, Manufacturing, and Supply Chain teams.
• Develop characterization protocols and report generation.

Skills

Engineering leadership

Data analysis

Technical writing

Bilingual English/Spanish

C&Q expertise

Education

MS in Engineering

BS in Engineering

Tools

GMP knowledge

Qualification protocols

Job description

We’re seeking Senior CQV Engineer to work for one of our top BiotechnologyIndustryclient at Juncos, PR. Salary: $45.00 hr – W2 Shift: Administrative shift(support a 24/7 manufacturing operations, some remote work is possible)

Why you should apply to be Senior CQV Engineer

• Competitive pay with biweekly direct deposit (W-2)
• Hands-on experience supporting critical manufacturing and quality systems in a leading biotechnology environment
• Collaborative, fast-paced, and dynamic workplace with growth opportunities
• Access to extensive training resources and career guidance
• Paid vacation, sick leave, holidays, and eligibility for a Christmas bonus (Must comply with minimum established requirements to qualify.)

This job might be an outstanding fit if you have the followingrequirements:

• MS degree in Engineering and 2years of directly related experience OR BS degree in Engineering and 4years of directly related experiencein pharmaceutical, biotechnology, or other regulated manufacturing industrie
• Experience leading Commissioning & Qualification (C&Q) strategies, planning, scheduling, and resource management in GMP environments.
• Strong expertise in FAT, SAT, startup, field commissioning, and IQ/OQ/PQ execution.
• Knowledge of ASTM E2500, ISPE guidance, risk assessments, and qualification lifecycle management.
• Experience authoring, reviewing, and approving qualification protocols, validation reports, and technical documentation.
• Strong understanding of GMP, FDA/EMA regulations, Data Integrity (ALCOA+), Change Controls, Deviations, and CAPA.
• Experience developing and executing process characterization studies, with strong technical writing, leadership, and project management skills.
• Proficient in data analysis and strong technical writing skills in English and Spanish.

The Senior CQV Engineer will be responsible for; C&Q Strategy & Planning: Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements. Commissioning Activities: Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning. Qualification Execution (IQ/OQ/PQ): Author, review, and approve qualification protocols (IQ, OQ, PQ). Documentation & Compliance:Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal company standards. Risk Management & Change Control: Lead and document risk assessments related to system qualification. Evaluate and manage change controls impacting validated systems. Assess impact of deviations and implement corrective and preventive actions (CAPA). Cross-functional Coordination: Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams. Characterization Process: Develop the characterization protocols. Execute the characterization activities. Develop and review the characterization reports

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