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.