Process Engineer

Actalent-posted 22 days ago
$50 - $60/Yr
Mid Level
Onsite • Irvine, CA
1,001-5,000 employees
Administrative and Support Services
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We are seeking a highly skilled and detail-oriented Process Engineer with a strong experience in validation engineering to support a strategic M&A integration project within the medical device industry. This fully onsite role in Irvine, CA requires a professional who can lead and execute validation activities, remediate documentation, and ensure seamless integration of acquired manufacturing processes and systems.

  • Lead and execute Test Method Validations (TMVs), Measurement System Analyses (MSAs), Equipment Validations (IQ/OQ/PQ), and Process Validations in accordance with FDA and ISO standards.
  • Assess and revise Standard Operating Procedures (SOPs), work instructions, and other controlled documents to align with integration requirements.
  • Identify gaps in legacy documentation and processes; develop and implement remediation plans to ensure compliance and consistency.
  • Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and R&D teams to support integration activities.
  • Analyze process and validation data to identify trends, root causes, and opportunities for improvement.
  • Support risk assessments and change control processes related to integration and validation activities.
  • Ensure all validation deliverables are completed on time and meet regulatory and internal quality standards.
  • Background in process engineering and validation, including TMV (Test Method Validation), MSA (Measurement System Analyses), IQ/OQ/PQ, and FDA/ISO standards.
  • Bachelor's degree in Engineering, Life Sciences, or related field.
  • Minimum 5 years of experience in validation engineering within the medical device industry.
  • Proven expertise in TMV, MSA, equipment and process validation.
  • Strong knowledge of FDA regulations, ISO standards, and GMP requirements.
  • Proficiency in data analysis and statistical tools.
  • Excellent written and verbal communication skills.
  • Ability to work independently in a fast-paced, cross-functional environment.
  • Experience with document control systems and electronic quality management systems (eQMS).
  • Experience with M&A integration and understanding of post-acquisition process harmonization.
  • Prior experience in integrating acquired manufacturing operations.
  • Medical, dental & vision
  • Critical Illness, Accident, and Hospital
  • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
  • Life Insurance (Voluntary Life & AD&D for the employee and dependents)
  • Short and long-term disability
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off/Leave (PTO, Vacation or Sick Leave)
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