Process Engineer

Actalent•Irvine, CA

73d•$50 - $60•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.