Jr. Controlled Environment Engineer
Job Description
Job DescriptionCompany Overview:
Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life.
Position Overview:
This position is responsible for assisting in maintaining, and monitoring controlled environments such as cleanrooms, laboratories, and other sterile or controlled spaces. This role involves working closely with the team to ensure that these environments meet the necessary safety, quality, and regulatory standards. The junior engineer will take direction from the senior engineer/manager and will be responsible for performing a range of technical tasks. Through your attention to detail and technical expertise, you will contribute to the success of the team by ensuring compliance and optimizing processes within controlled environments.
Responsibilities:
- Support Routine Monitoring and maintenance of proper environmental conditions, such as temperature, humidity, and airflow while adhering to safety and regulatory guidelines
- Support the senior engineer in conducting risk assessments and implementing mitigation measures to ensure a safe working environment
- Collaborate with cross-functional teams; including facility management, quality assurance, and production, to ensure that controlled environments meet operational requirements
- Conduct routine inspections and maintenance of equipment used in controlled environments, following maintenance schedules and documented procedures
- Monitor and analyze environmental data (e.g., temperature, pressure, particle count) and take corrective actions as needed with support of senior engineer/manager
- Assist in troubleshooting and resolving issues related to environmental controls, collaborating with relevant teams to identify root causes and implement corrective measures
- Maintain accurate and up-to-date documentation, including standard operating procedures (SOPs), maintenance logs, and calibration records
- Ensure compliance with applicable regulatory guidelines, such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Occupational Safety and Health Administration (OSHA) requirements
- Stay informed about industry advancements, new technologies, and best practices related to controlled environments, and provide recommendations for process improvements as appropriate
- Handle and dispose of hazardous waste materials according to safety protocols
- Assist in internal and external audits, as needed.
- Comply with all safety procedures and protocols
- Identify and report safety hazards or concerns
- Complete and/or participate in validation activities
- Investigate any deviations in cleanroom operations
Qualifications and Skills:
- Experience Knowledge and understanding of controlled environments, cleanroom technology, and relevant industry regulations (e.g., ISO 14644, cGMP)
- Strong analytical and problem-solving skills, with attention to detail and ability to identify and propose solutions to technical issues
- Excellent communication skills, both verbal and written, with the ability to collaborate effectively within multidisciplinary teams
- Proficiency in using software tools for data analysis and presentation
- Ability to work independently, prioritize tasks, and meet deadlines
- Flexibility in adapting to changing priorities and willingness to learn new technologies and techniques
- Basic knowledge of laboratory equipment and instrumentation is desirable
- Experience working in a controlled environment or maintaining environmental controls is a plus
Education: Associates Degree with some related experience
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