Process Validation Engineer

Tranzeal is an industry leading global Business Transformation Service Provider offering specific consulting services as well as pre-packaged, industry specific solutions and services to companies around the world. Our Consulting Services are dedicated to helping our clients maximize their investments in IT and the overall effectiveness and efficiency of the business. Tranzeal s deep industry experience makes us the partner of choice for a growing number of Fortune 1000 companies, midsize enterprises and small businesses worldwide.

We are currently looking for 'Process Validation Engineer' to support one of our clients with the following skills:

Requirement:

Role: Process Validation Engineer
Location: Tucson, AZ

Duration: 12+ months

Description:

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.

The national base pay range below is a good-faith estimate of what our client may pay for new hires. Actual pay may vary based on Client's assessment of the candidates knowledge, skills, abilities (KSAs), related experience, education, certifications and ability to meet required minimum job qualifications. Other factors impacting pay include prevailing wages in the work location and internal equity. $50,000 - $80,000

Note: Please send your updated resumes to sureshs(at)tranzeal(dot)(com)