Sr. Validation Engineer Medical Devices

BEPC has an Irving TX open position for a Sr. Validation Engineer Medical Devices to join our fast-growing team of consultants!

• Contract W2 Period : 1 year with possibilities for extension
• Pay & Benefits : + Medical, Dental, Vision & Life Insurance
• Location : Irving TX

SECTION 1 : JOB SUMMARY*

This Engineer is responsible to manage the plant wide facilities changes that are scheduled at Mentor, Irving Texas. The person must also ensure no disruption to current process / operations. .

SECTION 2 : DUTIES & RESPONSIBILITIES*

• Ensure that current and future manufacturing operations are not disrupted during the upgrades.
• Manage all contractors that are performing work at the site
• MUST have experience and familiarity with managing manufacturing plant facilites.
• Experienced in managing plant site large expansions and or large transfers is preferred.
• Experienced in project management in a medical device manufucturing plant IS REQUIRED.
• Comply with all applicable federal, state and local laws / regulations and Corporate Johnson & Johnson, procedures and guidelines, this position :
• Develops and leads execution of validation protocols.
• Provides suppot in work instructions and test methods as required by the introduction of new equipment / manufacturing flows
• Supports training for protocols, new / updated work Instructions and / or test methods
• Leads and supports prototyping builds for new product introductions
• Participates in the design of new equipment and assembly tools required for introduction of new products.
• Contributes with the development and design of the new manufacturing process
• Conducts root cause investigations and writing technical reports
• Recommends changes to standard operational and working practices.
• Prepares and maintains accurate documentation for adherence to GMP, FDA, and ISO regulations.
• Supports the stabilization process for the introduction of new products
• Performs laboratory testing for development and validation activities for the introduction of new products.

SECTION 3 : EXPERIENCE AND EDUCATION*

• A minimum of 5 - 7 years of experience in the Medical Industry is required.
• Bachelor’s Degree in Mechanical Engineering, Industrial, Electric / Electronic, or equivalent combination of education is required.
• Masters degree preferred.

SECTION 4 : REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS / LICENSES and AFFILIATIONS*

• Competent communication skills, both written and verbal are required.
• Demonstrated knowledge experience in Plant wide project Managment
• Knowledge and experience in IQ / OQ / PQ activities is required
• Good organizational skills and the ability to handle multiple tasks required.
• Strong computer background (MS Office, PowerPoint, Word, Excel, Outlook etc.) is required
• Experience in GMP industry is required
• Experience in performing non-conformance root cause investigation is preferred.
• Lean manufacturing / Six Sigma Process Excellence experience preferred.

MUST have experience in managing plant wide projects and preparing and making presentation to Sr. and Corporate Staff.