***Relocation assistance and visa sponsorship is not available for this position***
Come join Millstone Medical and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work!
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.
What's in it for you?
A company committed to quality, growth, career pathing.
At Millstone, we want you to be your best at work and at home. In addition to competitive compensation, we have designed our Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families.
To learn more about Millstone Medical Outsourcing, please visit us online at www.millstonemedical.com.
Job Summary:
The Validation Engineer is responsible for executing and documenting equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment and end-of-line processes. This role involves creating manufacturing work instructions, interfacing with customers on technical issues, and supporting project timelines. The Validation Engineer will also actively participate in cross-functional teams to identify root causes and implement corrective actions for issues encountered during investigations. Depending on the level of the position, the Validation Engineer may lead projects of moderate scope and duration or independently perform detailed engineering tasks.
Key Responsibilities:
Equipment and Process Validation:
Document and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for various manufacturing equipment and end-of-line processes.
Ensure that all validations are conducted in accordance with Good Manufacturing Practices (GMPs) and meet customer and regulatory requirements.
Manufacturing Work Instructions:
Develop, maintain, and update manufacturing work instructions to ensure that validated processes are accurately followed in production.
Collaborate with operations and quality teams to ensure work instructions are clear, concise, and effective.
Customer Interface:
Serve as a technical liaison between the company and customers, addressing technical issues, project timelines, and validation support.
Communicate effectively with customers to manage expectations and ensure alignment on validation activities.
Cross-Functional Team Participation:
Actively participate in cross-functional teams to investigate and determine the root cause of issues and develop corrective actions.
Collaborate with Quality, Manufacturing, and R&D teams to support continuous improvement initiatives and resolve validation-related challenges.
Operational Support:
Provide ongoing support to operations by troubleshooting issues related to validated processes and equipment.
Communicate effectively with Program Managers to ensure alignment on project goals and timelines.
Training and Development:
Train operations personnel on validated processes, work instructions, and equipment operation to ensure compliance with established procedures.
Mentor junior engineers or technicians as needed.
Project Management (Depending on Position Level):
Lead projects of moderate scope and duration, including defining project scope, schedule, team roles, and responsibilities.
Independently perform and coordinate detailed phases of engineering work, ensuring project tasks are completed on time and within budget.
Skills Required:
Education:
Bachelor's degree in Engineering is required.
Experience:
Depending on the level of the position, 4-8 years of relevant experience in validation engineering, preferably in a manufacturing environment.
Experience with IQ, OQ, and PQ protocols is required.
Knowledge of Good Manufacturing Practices (GMPs) is essential.
Technical Writing:
Strong technical writing skills are required to develop and document client process validations.
Communication and Problem-Solving:
Excellent communication skills, both verbal and written, to interface effectively with customers, cross-functional teams, and operations personnel.
Exceptional attention to detail, analytical abilities, and problem-solving skills.
Independence and Leadership (Depending on Position Level):
Ability to work independently and initiate/manage communications with customers.
Ability to negotiate with clients on project timelines, processes, and validation activities.
Experience in developing systems to improve standard processes is preferred.
ADDITIONAL INFORMATION:
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.