HCG Process Engineer - Horizon Controls Group
Boston, MA 02026
About the Job
As a Process engineer, you will mechanically troubleshoot, support identification and implementation of process improvements, system design, capital project support, and investigation support.You will also ensure all documentation deliverables are generated and develop new processes and/or optimize existing ones.
Responsibilities:
- Acts as the SME for critical process operations within filling and packaging operations.
- Must have project management skills, knowledge and application experience of technical design reviews, commissioning, and validation for pharmaceutical processes.
- Work routinely with cross functional groups throughout the site for process improvements and implementation.
- Interface with auditors and presenting on-site processes.
- Leads FAT (factory acceptance testing) and ensures protocol execution is per plan, supports installation, operational, and performance qualification activities.
- Direct the work of other process engineers and contract engineering resources, to include performance evaluations for direct reports.
- Establish methods for ongoing monitoring/trending of process/mechanical issues and will be responsible for review and approval of site documents to include calibration reports, batch records, SOP’s, change control, and design specs.
Requirements
- Bachelor of Science in Engineering or related science field, or technical equivalent
- Minimum of 5 years of experience as a Process Engineer at a pharmaceutical manufacturing plant, along with interdepartmental project leadership – management
- Solid understanding and knowledge of pharma regulations and cGMP
- Experience with technical design reviews, commissioning, and validation for pharmaceutical processes.
- Mechanical aptitude to trouble shoots and identify issues; you have a proactive mindset for maintenance and
- Ability to refine and develop new processes to improve production and efficiencies
- Direct experience writing documents e.g. calibration reports, batch records, SOP’s, change control, and design spec
- Proactive customer centric communication style and the ability to development and maintain interdepartmental partnerships
Horizon Controls Group is a company rooted in human-centric values. We are dedicated to fostering diversity, equality, inclusion, and a deep sense of belonging within our organization. We firmly believe that by creating an environment where our diverse team members can freely exchange ideas and thrive, we are better equipped to serve both our organization and our diverse global clientele. We empower our staff to feel valued, connected, and capable of making meaningful contributions to the communities they are part of, both personally and professionally. Above all, we want each employee to be proud to be a member of Horizon Controls Group.
Bachelor of Science in Engineering or related science field, or technical equivalent Minimum 3+ years of experience in the Quality Assurance field working with ISO 13485, FDA Quality System Regulations, and Medical Device Directive requirements Minimum 1 year utilizing corrective and preventive action (CAPA) system, in compliance with US federal and international regulatory standards relating to medical devices Minimum 1 year experience in Nonconforming Product Management Minimum 1 year experience in Complaints investigation Minimum 1 year Utilization of root cause analysis tools, including fishbone diagrams, fault tree analysis, 5 Whys, Is/Is Not Process validation; statistical process control, root cause investigation, and use of problem-solving tools Basic knowledge of Lean Manufacturing and Continuous Improvement concepts and tools Nice to have, but not required Experience working in an electro-mechanical assembly manufacturing environment Specialized Training: FDA GMP training; Basic statistical including trends, pareto and other basic charting techniques Training with basic statistical including trends, pareto and other basic charting techniques Desirable Lean Six Sigma Green Belt Certification Horizon Controls Group is a company rooted in human-centric values. We are dedicated to fostering diversity, equality, inclusion, and a deep sense of belonging within our organization. We firmly believe that by creating an environment where our diverse team members can freely exchange ideas and thrive, we are better equipped to serve both our organization and our diverse global clientele. We empower our staff to feel valued, connected, and capable of making meaningful contributions to the communities they are part of, both personally and professionally. Above all, we want each employee to be proud to be a member of Horizon Controls Group.
Source : Horizon Controls Group