Process Validation Engineer

Description: On site in Tucson

This is in the Engineering category

We are seeking a highly motivated and detail-oriented Process Validation Engineer with 1-3 years of experience to join our team. The Process Validation Engineer will be responsible for developing and executing process validation and/or process verification protocols and reports to ensure that manufacturing processes are compliant with regulatory requirements and company standards. This role involves collaborating with cross-functional teams to support continuous improvement and maintenance of validated processes.

Responsibilities:

• Develop, write, review, and execute process validation/process verification protocols

and reports.

• Conduct risk assessments and develop validation strategies for new and existing

processes.

• Analyze and interpret process validation data, ensuring accuracy, completeness, and

adherence to regulatory and internal requirements.

• Collaborate with Manufacturing, Quality, Design Transfer Operations, and other

departments to resolve validation issues and implement corrective actions.

• Participate in process optimization and continuous improvement initiatives to enhance

quality and efficiency.

• Ensure compliance with FDA, ISO, and other relevant regulatory guidelines, as well as

adherence to internal requirements.

• Provide training and guidance to manufacturing and quality personnel on validation

processes and procedures.

• Maintain process validation documentation and ensure traceability and accessibility for

audits and inspections.

• Other duties as assigned by management.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field.

• 1-3 years of experience in process validation within a regulated industry

(pharmaceutical, medical device, biotechnology, etc.).

• Strong understanding of process validation principles, techniques, and industry

standards.

• Familiarity with regulatory requirements (FDA, ISO) and Good Manufacturing Practices

(GMP).

• Excellent analytical, problem-solving, and critical-thinking skills.

• Strong written and verbal communication skills.

• Ability to work both independently and as part of a multidisciplinary team.

• Detail-oriented with strong organizational and time-management skills.

• Proficient in Microsoft Office Suite (Word and Excel), Google Workspace

Preferred Qualifications:

• Experience with statistical analysis software (e.g., Minitab, JMP).

• Previous experience in a cleanroom or controlled environment.

• Knowledge of Six Sigma or Lean methodologies.

EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.