Practical Applications
VALIDATION ENGINEER I
Practical Applications, Boston, MA, United States
VALIDATION ENGINEER I
We Deserve the Best - And So Do You!
High Growth Company
Opportunity to Learn and Grow
Shape your Career
See the Importance of Your Work
Millstone Medical Outsourcing is looking for an energetic individual to join its Engineering Department as Validation Engineer I. 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.
SUMMARY: The Validation Engineer I will be responsible for working with the Millstone Medical Engineering Team to ensure the successful execution of equipment & process validations.
RESPONSIBILITIES:
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 may other voluntary benefits in addition to an employee-centric work environment. To learn more about Millstone Medical Outsourcing's opportunities, 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.
We Deserve the Best - And So Do You!
High Growth Company
Opportunity to Learn and Grow
Shape your Career
See the Importance of Your Work
Millstone Medical Outsourcing is looking for an energetic individual to join its Engineering Department as Validation Engineer I. 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.
SUMMARY: The Validation Engineer I will be responsible for working with the Millstone Medical Engineering Team to ensure the successful execution of equipment & process validations.
RESPONSIBILITIES:
- Document and execute equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment and end-of-line processes
- Creation of manufacturing work instructions
- Interface with customers on technical issues, project timeline, and validation support
- Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations
- Provide support for operations and communicate with Program Managers
- Assist with training of operations personnel
- All other duties as assigned
- Bachelor's degree in Engineering
- 1 year relevant experience
- Technical writing proficiency to develop client process validations
- Excellent communication skills
- Excellent attention to detail, analytical and problem-solving skills
- Experience with IQ, OQ and PQ protocols
- Knowledge of GMPs
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 may other voluntary benefits in addition to an employee-centric work environment. To learn more about Millstone Medical Outsourcing's opportunities, 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.