Senior Validation Engineer -Medical Device

Validation Staff Engineer - Medical Device

Direct Hire (No C2C)

Location: Middletown, VA 22645

Salary: $120,000 -130,000 + Full Benefits Package and Bonus Potential

Overview: Our client is looking for a Validation Staff Engineer located in Middletown, VA. Their customers globally rely on their extensive range of products and services from life-saving medicines to lab essentials to next-generation instruments. The operations team leverages PPI (Practical Process Improvement Business System) to manufacture and produce these products and continuously improve productivity and quality all while contributing to the Mission - to enable our customers to make the world healthier, cleaner, and safer.

Responsibilities:

Responsible for leading / assisting the validation team in supporting all site validation activities. This includes automation equipment, product transfers, new product development, and working as part of a cross-functional team responsible for sustaining change. An active participant in the origination of design concepts and specifications, process/technology development, product verification/validation, project planning, and other applicable documentation while adhering to quality and manufacturing requirements.

Serve as the primary interface between Operations and Quality Assurance.

Originate and assist in the preparation and approval of change orders related to the operation and improvement of manufacturing processes.

Assist the validation team in maintaining the Site Validation Master Plan.

Support development projects, transfer projects, process changes, and engineering projects to provide overall guidance as it relates to quality standards, inspection techniques and FMEA

Direct and oversee validation activities for Operations, Engineering, Quality Assurance, and other functional areas.

Review, revise, and maintain site validation procedures, qualification protocols, and associated data in accordance with FDA and ISO requirements.

Lead and/or assist in training of staff involved in validation activities.

Assist Quality, Operations, and Engineering personnel during inspections or audits.

Requirements:

Bachelor degree from a four-year college or university and 5+ years of relevant experience or in the pharmaceutical, medical device, or in-vitro diagnostics industry with progressively increasing responsibilities.

Or Associate degree and 10+ years of relevant experience in the pharmaceutical, medical device, or in-vitro diagnostics industry with progressively increasing responsibilities is required.

Must be proficient on validation protocol development, technical writing, data analysis, and report generation. i.e.; IQ, OQ, PQ, FAT, SAT as an example.

Must have knowledge of process + packaging equipment, and software validation principles and concepts.

Must have high level of expertise concerning current validation principles and regulatory requirements.

Strong understanding and proficiency in cleaning validation and cleaning process design.

Must be proficient in statistical analysis and process control.

Must be able to resolve conflicts between requests for process change and the validation requirements for those processes.

Independent self-starter capable of planning schedules, controlling plans, and leading projects as assigned.

Must ensure adherence to FDA and ISO requirements throughout the product life cycle.

Develop and execute verification and validation plans and protocols associated with product/process quality according to FDA and ISO requirements.

ability to manage multiple projects simultaneously without supervision. This includes creating detailed and accurate project tasks and schedules, interfacing with project team members and support personnel, and solving project-related conflicts and issues.

Strong working knowledge of design and process controls.

Knowledge of global regulatory and quality requirements associated with medical devices. Working knowledge of ISO 13485 and 21 CFR Part 820.

Preferred Qualifications:

Proficiency in Microsoft Office products (i.e. Mini Tab, Excel, Outlook, PowerPoint, etc.).

Working knowledge of ISO 13485 and 21 CFR Part 820.

Knowledge of global regulatory and quality requirements associated with medical devices.

Previous medical device (Class II or Class III) experience required (from product development, validation engineering, sustaining engineering or manufacturing engineering).

Proficiency with various software platforms such as Minitab, Blue Mountain RAM, and Master Control is preferred.

Client is not able to provide H1B sponsorship right now but may be available in the future