Process Validation Engineer 2

Acumed LLC

Come join a team where People make the difference!As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.

Job Scope

The Process Validation Engineer 2 oversees testing of systems and processes to ensure the highest quality products are manufactured.

Investigates process deviations, assignable root causes for equipment, system or process failures and establishes appropriate corrective, preventive actions as well as supporting all quality activities related to the production and inspection of sustaining products.

The PVE ensures processes are performed and documented accurately, timely and in compliance with SOPs, cGMPs and FDA requirements in an ISO 13485 environment.

Responsibilities

• Functions as SME on data collection and statistical analysis for internal partners
• Guide validation efforts ensuring compliance with policies and global regulations
• Provides process validation engineering support throughout the product lifecycle
• Provides support with development, engineering and manufacturing functions for validation planning and transfer activities
• Reviews / approves internal and supplier generated validation protocols / reports
• Reviews / approves validation reports, identifies gaps for cGMP compliance, develops and executes strategies to close gaps in an efficient, technical, and compliant manner
• Organizes and presents qualification data, results, documentation, and reports within the appropriate equipment / system validation files and system manuals with guidance of other PVE's
• Supports internal and external audits
• Handles Non-Conforming Material Reports system and dispositions non-conforming products
• Creates / maintains final inspection plans, works with SMEs to develop and validate inspection methods
• Leads and supports quality investigations and root cause determinations
• Serves on cross functional teams to resolve quality issues
• Interfaces with suppliers on quality issues

Qualifications

• 2+ years experience in QA in a regulated environment
• Bachelor’s Degree or 8+ years experience in QA in a regulated environment
• Experience working with implantable devices preferred
• 2+ years experience applying quality regulations and standards (e.g., 21CFR 820, ISO 13485, ISO 14971, etc.)
• Experienced in the development and execution of qualification protocols (IQ / OQ / PQ) and validation documents
• Experience with CAPA and failure investigation tools / techniques
• Experience working with external suppliers
• Highly effective communicator
• Proven track record of participating in teams and delivering results, adaptable to fast-paced, dynamic environment with shifting demands
• Working knowledge of ERP Systems (SAP)
• ASQ Certified Quality Engineer desired
• Proficient in MS Office Suite; Minitab experience preferred
• Experienced with Good Documentation Practices (GDP)

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class.

If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to , and please be sure to include the title and the location of the position for which you are applying.