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.