Validation Engineer II

Validation Engineer II

Apex Systems is seeking a Validation Engineer II to join our client within the medical device industry. The position will be a 6 month contract with potential to extend.

• Provide engineering support for sustaining operations.
• Manage document and process changes using Change Control system.
• Develop equipment specifications and qualification protocols & reports in line with company corporate validation (IQ/OQ/PQ) and software verification requirements.
• Support Preventative Maintenance and Calibration setup for equipment.
• Analyze data using statistical and process capability tools, such as Mini Tab.
• Experience with root cause analysis tools and techniques, with a specific focus on process capability.
• Execute assigned project tasks within cost and schedule requirements. Working with team of engineers assisting them in bringing projects to successful conclusion.
• Develop reporting methodologies for Cpk, Ppk metrics and implementation of SPC.
• Actively participate in and support company and plant wide initiatives including six-sigma, lean, safety and cost reduction.
• Identify continuous improvements opportunities where possible and take part in improvement projects as assigned and carry out additional duties that may be assigned.
Skills:

Experience working within a regulated industry with knowledge of MDD (Medical Device Directive), ISO 13485 (Quality Management Systems), FDA, cGMP, and Risk Management (ISO 14971). Experience with project management responsibility preferred. Ability to work with cross-functional teams, including production, quality, engineering and materials. Experience working with automated assembly processes is desirable. Excellent time management. Must be able to multitask and operate in a fast-paced environment with minimal training and supervision.

Strong written, verbal, and interpersonal skills. Ability to effectively interact with all levels of employees and management, both in the manufacturing group and cross-functionally Excellent computer skills including advanced working knowledge of Microsoft Office (Word, Excel, Outlook, etc.). Working experience with Software Validation, Cleaning Validations, Packaging Validations, Sterilization Validations, and Product & Process Performance Qualifications (PQ) preferred.

Education:

Bachelor's Degree in Engineering discipline or equivalent experience.

3 to 5 years experience working in the medical device industry with focus on validation activities and manufacturing process capability. Proficient in Minitab and statistical data analysis. Experience working in a quality engineering role with active involvement with the manufacturing floor. Six Sigma/ Lean Manufacturing certification and previous eDHR experience preferred.