HCG Process Engineer
2 weeks ago
Boston, United States
| Posted on 04/26/2024
As a Process engineer,you will mechanically troubleshoot, support identificationand implementation of process improvements, system design, capital projectsupport, and investigation support.
You will also ensure all documentationdeliverables are generated and develop newprocesses 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 ofexperience as a Process Engineer at a pharmaceutical manufacturing plant, along with interdepartmentalproject leadership – management
Solidunderstanding and knowledge of pharma regulations and cGMP
Experience with technicaldesign reviews, commissioning, and validation for pharmaceutical processes.
Mechanicalaptitude to trouble shoots and identify issues; you have a proactive mindset formaintenance and
Ability to refine anddevelop new processes to improve production and efficiencies
Direct experiencewriting documents e.g. calibrationreports, batch records, SOP’s, change control, and design spec
Proactive customercentric communication style and the ability to development and maintain interdepartmentalpartnerships
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.
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