SENIOR VALIDATION ENGINEER
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Millstone Medical Outsourcing is looking for an energetic individual to join its Engineering team as a Senior Validation Engineer. Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstone's business focus is sterile and non-sterile packaging of medical devices.
Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy, and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance
This position bears the potential for significant growth in a technical or management career track.
JOB SUMMARY:
The Senior Validation Engineer will be responsible for leading the engineering team to ensure that all tasks associated with validation activities are completed successfully.
RESPONSIBILITIES:
Serve as a principle technical expert regarding validation activities associated with equipment and processes
Perform process analysis, improvements, along with equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment and end-of-line processes
Generate clear and concise work instructions, test methods, and visual standards
Have a firm understanding of validation strategy (IQ, OQ, PQ), support protocols and reports
Interface and negotiate with customers on technical issues, project timelines, and validation support
Actively lead and participate on cross functional teams
Provide technical support for operations involving day to day troubleshooting and communicate with Program Managers
Provide training of operations personnel
Institute and apply best engineering practices to processes to facilitate high quality output and efficient throughput
Ensure effective use of designs, material, equipment, and personnel throughout operations
Negotiate and administer facility engineering services, materials, and equipment contracts as appropriate
Participate in the development and implementation of facility engineering technology and automation solutions to increase sustainability and operational efficiency
Possess strong communication and interpersonal skills to build relationships with employees across the organization, including key client groups, peers, senior management, and subordinates
Ensure process validation program is robust and compliant
Develop and maintain re-validation program with risk-based approach
Facilitate and/or support validation training, project management activities as required, and support change management
Contribute to the effectiveness of the quality system by activity participating in NCR's, complaints, CAPA's, and root cause investigations.
Mentor junior engineers
Act as document approver
All other duties as assigned
KNOWLEDGE & SKILLS :
Bachelor of Science in Mechanical Engineering/Chemical Engineering/Bioengineering with 5-8 years engineering experience. Less years of experience may be considered with a master's degree.
Experience in managing and executing projects
Strong interpersonal and organizational skills
Possess excellent leadership and project management skills
Must be capable of multi-tasking and performing assignments that have loosely defined objectives
Ability to effectively communicate verbally and in writing
Must be able to plan, coordinate, perform, and supervise contract staff with minimal oversight
Ability to apply fundamental engineering principals to resolve issues relating to processing equipment and product launches
Ability to apply working knowledge of applicable regulatory standards (FDA, ISO, OSHA, EPA, CFR, etc.) and good understanding in GMP requirements and validation processes
Must be able to prioritize critical versus non-critical issues and communicate to management
Ability to establish credibility and trust amongst all levels of the organization
Act at high integrity and influence decisions impacting the performance of the site
Ability to work under tight timelines and be able to motivate others to deliver expected results
Please note that this position is not eligible for visa sponsorship.
ADDITIONAL INFORMATION:
Millstone Medical Outsourcing offers a competitive salary, health, dental and vision benefits beginning on the first day of employment and 401K with company match. Other benefits include paid vacation, paid sick time, holiday pay, tuition reimbursement and many other voluntary benefits in addition to an employee-centric work environment. To learn more about Millstone Medical Outsourcing, please visit us online at www.millstonemedical.com.
Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.
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