<p>Job Title: Process Engineer</p> <p>Job Description</p> <p>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.</p> <p>Responsibilities</p> <ul> <li>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. </li><li>Assess and revise Standard Operating Procedures (SOPs), work instructions, and other controlled documents to align with integration requirements. </li><li>Identify gaps in legacy documentation and processes; develop and implement remediation plans to ensure compliance and consistency. </li><li>Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and R&D teams to support integration activities. </li><li>Analyze process and validation data to identify trends, root causes, and opportunities for improvement. </li><li>Support risk assessments and change control processes related to integration and validation activities. </li><li>Ensure all validation deliverables are completed on time and meet regulatory and internal quality standards. </li></ul> <p>Essential Skills</p> <ul> <li>Background in process engineering and validation, including TMV (Test Method Validation), MSA (Measurement System Analyses), IQ/OQ/PQ, and FDA/ISO standards. </li><li>Bachelor's degree in Engineering, Life Sciences, or related field. </li><li>Minimum 5 years of experience in validation engineering within the medical device industry. </li><li>Proven expertise in TMV, MSA, equipment and process validation. </li><li>Strong knowledge of FDA regulations, ISO standards, and GMP requirements. </li><li>Proficiency in data analysis and statistical tools. </li><li>Excellent written and verbal communication skills. </li><li>Ability to work independently in a fast-paced, cross-functional environment. </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>Experience with document control systems and electronic quality management systems (eQMS). </li><li>Experience with M&A integration and understanding of post-acquisition process harmonization. </li><li>Prior experience in integrating acquired manufacturing operations. </li></ul> <p>Work Environment</p> <p>This is a fully onsite role based in Irvine, CA. The work environment is fast-paced and cross-functional, requiring collaboration with various teams such as Quality, Regulatory, Manufacturing, and R&D. The position offers benefits such as 3 weeks of PTO and 10 paid holidays.</p> <p>Job Type & Location</p> <p>This is a Contract position based out of Irvine, CA.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $50.00 - $60.00/hr.</p> <p>Eligibility requirements apply to some benefits and may depend on your job</p> <p>classification and length of employment. Benefits are subject to change and may be</p> <p>subject to specific elections, plan, or program terms. If eligible, the benefits</p> <p>available for this temporary role may include the following:</p> <ul> <li>Medical, dental & vision </li><li>Critical Illness, Accident, and Hospital </li><li>401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available </li><li>Life Insurance (Voluntary Life & AD&D for the employee and dependents) </li><li>Short and long-term disability </li><li>Health Spending Account (HSA) </li><li>Transportation benefits </li><li>Employee Assistance Program </li><li>Time Off/Leave (PTO, Vacation or Sick Leave) </li></ul> <p>Workplace Type</p> <p>This is a fully onsite position in Irvine,CA.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Dec 8, 2025.</p> <p>About Actalent</p> <p>Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.</p> <p>The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.</p> <p>If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.</p>