Process Validation Engineer
About the role
The Process Validation Engineer supports high-profile, innovative product lines from initial concept through full-scale manufacturing. This role focuses on process validation, new product introduction, and manufacturing line support, ensuring robust, efficient, and compliant processes for novel medical products, including advanced tissue regeneration solutions and wound care hydrogels. You will collaborate closely with cross-functional teams to develop and optimize manufacturing processes, create and maintain technical documentation, and drive data-based decisions that align with business objectives in a fast-growing organization.
Responsibilities
- Support new product launches from initial concept to completion, including prototyping, testing, creation of technical documents and specifications, and transfer of processes to manufacturing.
- Develop and execute Master Validation Plans and Validation Protocols/Batch Records for new and existing product lines, ensuring processes are validated and compliant.
- Create and maintain detailed timelines for new product introductions and follow through on project tasks to ensure successful and timely launch completion.
- Work independently or in collaboration with other engineers and scientists to troubleshoot technical issues encountered during prototyping, scale-up, and manufacturing.
- Prepare Bills of Materials for new product lines and processes, collaborating with production, quality control, and ERP teams to develop accurate cost of goods estimates.
- Write or revise batch records and standard operating procedures to support new product introductions and process changes.
- Work closely with cross-functional teams such as R&D, Quality, Manufacturing, and Regulatory to make data-driven decisions that move projects forward and align with business goals.
- Perform scale-up and process optimization activities for existing products to improve performance, efficiency, and consistency.
- Ensure business continuity by providing support and prompt investigation and resolution of process performance drifts and CAPAs.
- Conduct and support risk analysis activities related to manufacturing processes and process changes, as needed.
- Assist with special ad hoc projects and other duties as assigned, contributing technical expertise to various engineering and validation initiatives.
- Provide manufacturing line support, helping to maintain stable and reliable production processes for current and new product lines.
Essential Skills
- 3–5 years of experience in an engineering role, preferably in process validation, manufacturing, or process engineering.
- Bachelor’s degree (B.S.) in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or Biomedical Engineering.
- Hands-on experience with process validations, including developing and writing validation protocols and related documentation.
- Ability to execute project deliverables according to established schedules and timelines.
- Demonstrated capability to work effectively within a team environment and build strong relationships with cross-functional partners such as R&D, Quality, Manufacturing, and Regulatory.
- Strong verbal and written communication skills, with the ability to clearly communicate to individuals at various levels within the organization.
- Experience with common problem-solving methodologies, including issue resolution, root cause investigations, and CAPA development and implementation.
- Technical writing skills for creating and revising batch records, standard operating procedures, and other technical documents.
- Proficiency in Microsoft Word, Excel, and PowerPoint for documentation, data analysis, and presentations.
- Experience in manufacturing process support and process optimization activities.
- Knowledge of risk analysis related to manufacturing processes (preferred).
- Experience in medical device or pharmaceutical environments, with a preference for medical device but openness to pharmaceutical backgrounds.
Additional Skills & Qualifications
- Experience with Minitab for statistical analysis and data-driven decision making is a plus.
- Experience with SolidWorks for design and engineering support is a plus.
- Experience with Microsoft Project for project planning and timeline management is a plus.
- Background in manufacturing line support, helping maintain and improve production processes.
- Exposure to tissue regeneration technologies or wound care products is beneficial but not required.
- Ability to manage multiple tasks and projects in a fast-paced, growth-oriented environment.
- Strong attention to detail and commitment to quality and compliance in all validation and documentation activities.
Work Environment
You will work on-site in a dedicated engineering environment alongside a team of approximately 9–10 engineers, including other integration and process validation specialists. The role is based in a collaborative setting where engineers work independently on their projects while maintaining close interaction with peers and cross-functional teams. Typical working hours are approximately 8:30 a.m. to 5:00 p.m., providing a structured daytime schedule. The environment is focused on supporting innovative, high-impact medical products, with access to modern engineering and validation tools and close collaboration with production, quality control, and other operational functions.
Pay
The pay range for this position is $48.08 - $65.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Benefits
- 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)