Process Engineer
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Job Location:
Allentown, GA - USA
Monthly Salary:
Not Disclosed
Posted on:
21 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
What will you do
The Process Engineer plays a pivotal role in supporting the Engineering and Operations teams in a GMP-regulated pharmaceutical packaging environment. Responsibilities include leading technology transfers driving capital equipment projects and integrating new assets and automation to optimize operational efficiency throughput and quality. The individual drives continuous improvement initiatives evaluates and implements process enhancements and assists in resolving advanced machine issues to maintain standardized and efficient operations.
How will you get here
Applicants should possess at least 3 years of engineering experience in a relevant cGMP controlled environment with a preference for the pharmaceutical or food industry. Those with 5-10 years of experience are highly desirable.
- Ensure full compliance with GMP standards site safety practices and what we value (Integrity Intensity Innovation Involvement).
- Assist in ongoing improvement efforts aimed at cutting costs boosting efficiency enhancing product quality and streamlining workflow.
- Lead technology transfer activities for new and existing client products including documentation qualification and alignment to project timelines.
- Drive capital expenditure (CAPEX) projects from initiation through equipment installation and operational integration.
- Develop equipment specifications and user requirements (URS or equivalent experience) lead vendor evaluations drive design reviews and perform FAT/SAT commissioning and validation activities.
- Onboard and integrate new equipment automation platforms and production technologies to improve throughput reduce manual operations and enhance control.
- Collaborate with Production and Operations to identify and resolve workflow bottlenecks and performance constraints across packaging lines.
- Support in resolving complex issues on packaging equipment working closely with maintenance OEMs and operators to identify root causes and implement sustainable solutions.
- Conduct deviation investigations CAPAs and change control management.
- Review develop and approve Engineering and Validation documents including protocols specifications and SOPs.
- Perform additional duties as needed to meet business and operational objectives.
Education:
A four-year Bachelor of Science degree from an accredited college or university in Packaging Electrical Mechanical or Industrial Engineering or a related field is required.
Knowledge Skills Abilities
- Proficiency in pharmaceutical or food packaging operations is required; Experience with automated packaging labeling bottling or device assembly equipment is preferred.
- Strong foundation in Lean Six Sigma SMED and structured problem-solving methodologies.
- Mechanical proficiency with proven experience resolving issues with packaging equipment.
- Proficient in authoring equipment onboarding and qualification documentation (URS FDS FMEAs FAT/SAT/Commissioning protocols SOPs Work Instructions).
- Strong written and verbal communication skills with the ability to explain technical information to non-technical collaborators including clients.
- Proficiency with MS Office especially Excel for data analysis and project tracking.
- Capable of supporting and advancing multiple priorities and working effectively in a fast-paced multi-functional environment.
Physical Requirements
- Ability to occasionally lift up to 10 lbs. and perform activities such as bending reaching and standing as needed.
Key Skills
- Lean Manufacturing
- Six Sigma
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Process Engineering
- cGMP
- Kaizen
- Programmable Logic Controllers
- Manufacturing
About Company
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