JOB TITLE:
Engineering Change Specialist
ABOUT US:
Cold Chain Technologies is a leading global provider of advanced thermal packaging assurance products, digital solutions and services for the transport of temperature-sensitive material, principally serving the pharmaceutical, biotech, diagnostics, health care and medical device industries. With more than 50 years of experience in ensuring product safety in transit, CCT has built a reputation as the industry's most innovative and reliable provider to the largest global life sciences companies and has had a history of vigorous growth. CCT today has the broadest portfolio of products, including the largest digitally enabled parcel shipper fleet in the industry. CCT also leads the industry in offering high performing, sustainable solutions, replacing fossil fuel-based materials.
The company’s headquarters is in Franklin, MA, and is ISO 9001: 2015 registered. CCT has additional facilities in Nashville, TN, Center Valley PA, Elgin, IL, Dallas TX, and San Diego, CA. CCT is also manufacturing and distributing products in Europe, Latin America and Asia, with significant growth coming through international expansion. CCT’s design and ISTA-certified testing laboratories are universally recognized throughout the industry as world-class.
JOB DESCRIPTION
The Change Control Specialist position is a hands-on role responsible for supporting configuration management, change management and release management activities. The position will work closely with the various departmental teams, such as Quality, Engineering, Marketing, Manufacturing and systems administrators where changes are needed.
Responsibilities:
- Review/triage/manage interaction and open communication with the engineering community and other departments to assure accuracy, completeness and issue resolution of all ECOs associated with developing and manufacturing products throughout their lifecycle.
- Process change requests using the SolidWorks PDM, PLM (Synergy or equivalent) and ERP (Epicor or equivalent) system.
- Work with cross functional teams to ensure all changes are implemented and versioning is done correctly, and dispositions are followed.
- Track Engineering Changes through the review and release cycle, ensuring timely approval and processing while maintaining the correct configuration.
- Work closely with Manufacturing Change Specialist to ensure all data is accurate when transitioning to Manufacturing and Epicor and at times may perform as a backup to the Manufacturing Change Specialist.
- Manage changes of part/BOM data in ERP enforcing governance process and controls.
- Follow up to ensure that the changes were implemented as specified.
- Troubleshoot issues and provide direction in resolving issues with submitted change requests.
- Administer the Configuration Management process in accordance with document procedures.
- As needed, provide ongoing direction to cross functional personnel, providing consistent service and sharing best practices with PLM (Synergy) & ERP (Epicor) user community
- Prepare, schedule and conduct Change Control Board (CCB) meetings.
- Represent Document Control at meetings
- Create and implement process improvements related to software configuration and deployment.
- Represent Document and Change Control team, collaborating with IT and other departments through projects, meetings and daily interaction to ensure the PDM and ERP systems are configured to facilitate efficient and effective Change Management workflows.
- As needed, provide assistance and training to users.
- Duties, responsibilities and activities may change, or additional new ones may be assigned
Requirements:
- Bachelor’s Degree in Engineering, Business or Information Technology, plus experience with a Quality Management System. In lieu of a Bachelor’s degree, an additional 4 years of relevant work experience is required in addition to the required work experience
- Demonstrated experience with change control & electronic document management systems
- Experience with Outlook, MS Word, ADOBE (PRO), Excel, PowerPoint, Visio & other MS software
- Ability to independently troubleshoot issues with electronic document management systems
- Ability to problem solve and manage multiple tasks while assisting internal customers
- Ability to provide a high degree of service to internal customers
- Thorough understanding of Bills of Materials [BOMs] and Bills of Operations [BOOs].
- Thorough knowledge of manufacturing processes and material flow.
- Thorough knowledge of part activation and ECR/ECO processes.
- Thorough knowledge of reading technical drawings
- Experience working in ERP systems, knowledge of Epicor E10 ERP system a plus.
- Excellent written, verbal communication skills as well as strong organizational skills, attention to detail and follow up skills
Other Requirements (License, Permit, Certification, Travel, Physical etc.):
- CMII certification would is a plus but not needed.
- Available for occasional travel
