Process Engineer III

Title: Process Engineer III
Duration: 6 months+ Possible Extension
Location: Swiftwater, PA
Pay Range: $68/hr- $73/hr

Manager Notes:

• Fully onsite position, however, may offer 1 day off site, day of the week varies, at manager's discretion.
• Bachelors degree, engineering life sciences, engineering open all levels
• 5 years of experience, open to all levels

Must have :

• Biotech, Pharma experience

Top skills:

• CAPA Change Controls Authoring of documents of protocols

Preferred:

• Vault or Calipso, or GMP Compliance document system or similar
• Quality background is a plus, manufacturing and or validation
• Knowledge of ERP systems (iShift preferred)
• Root Cause Analysis, inspections

Description:
Providing Continuous Improvement Initiatives for Formulation and Filling Areas (FFIP).

PROJECT SUMMARY:
This Product of Work defines the role and responsibilities of a Continuous Improvement Contractor at the Client Swiftwater, PA facility. The Continuous Improvement Contractor will provide dedicated support to the Continuous Improvement Group, with primary focus on the Formulation and Filling Areas. This position reports to and is overseen by the Deputy Director, Continuous Improvement (Formulation and Filling)

2 TECHNICAL TASKS AND DELIVERABLES / Product
The Continuous Improvement Contractor will execute the following activities and responsibilities:
2.1 Cross-Functional Collaboration and Support
Serve as an individual contributor and active member of cross-functional teams providing support to Production Control Units (PCUs)
Act as CAPA (Corrective and Preventive Action) and Change Control point of contact for the Formulation and Filling Improvement Program (FFIP), with emphasis on Formulation and Filling areas
Facilitate cross-functional interfacing activities with key stakeholders in a positive and collaborative manner, including, but not limited to:
o Quality Control
o Manufacturing Science and Technology (MSAT)
o Sterility Assurance
o Engineering
o Operations
o Quality Assurance
2.2 CAPA and Change Control Management
Complete all required training to independently own CAPA action items, Change Control action items, and author related documents
Ensure timely closure of assigned CAPA and Change Control action items
Maintain accountability for deliverables and adherence to established timelines
2.3 Technical Support and Process Improvement
Provide technical support for:
o Component qualification activities
o Overall Equipment Effectiveness (OEE) improvement initiatives
o Electronic Batch Record (eBR) implementation and optimization
o Opstrakker system utilization
o General factory improvement projects
Facilitate resolution of unresolved issues and deliverables by:
o Leading cross-functional meetings
o Positively influencing functional managers
o Removing obstacles and barriers to progress
o Managing projects and competing priorities effectively
2.4 Operational Excellence and Metrics Management
Create and maintain a proactive operational environment
Monitor and communicate key performance metrics to team members and support functions
Utilize the "+QDCI" Visual Management Systems to drive continuous improvement in key metrics
Work within the Continuous Improvement framework to identify and implement improvement opportunities
2.5 Compliance and Quality Assurance
Ensure strict compliance with all regulatory requirements and current Good Manufacturing Practices (cGMPs)
Maintain adherence to good documentation practices to ensure delivery of safe, quality, and effective products
Support regulatory inspections and audits as required

3 REQUIRED SKILLS AND QUALIFICATIONS
3.1 Technical Knowledge and Expertise
Manufacturing Operations: Deep understanding of cGMPs and pharmaceutical manufacturing activities, including:
o Formulation processes
o Filling operations
o Lyophilization (freeze-drying) processes
Continuous Improvement Methodologies:
o Comprehensive knowledge of Lean Manufacturing concepts and principles
o Six Sigma methodology and tools
Change Management: Demonstrated experience in Change Management processes and execution
Protocol and Report Development: Proven experience in authoring protocols and technical reports
3.2 Systems and Tools Proficiency
Microsoft Office Suite: Proficient in Excel, Word, and PowerPoint
Enterprise Resource Planning (ERP): Knowledge of ERP systems (iShift preferred)
Quality Management Systems: Experience with Quality Management Systems (Qualipso)
Electronic Systems: Familiarity with eBR and Opstrakker systems
3.3 Core Competencies and Soft Skills
Communication: Excellent interpersonal and communication skills with ability to engage effectively across all organizational levels
Leadership: Strong management by influence skills; ability to lead and actively participate on cross-functional teams
Technical Writing: Excellent technical writing skills for generation of protocols, reports, and Change Controls
Project Management: Strong project management and organizational skills
Time Management: Demonstrated ability to prioritize tasks and manage time effectively in a fast-paced environment
Flexibility: Adaptability to change priorities and business needs
Problem-Solving: Analytical mindset with ability to identify root causes and implement effective solutions

4 Schedule
Major required milestones to support the project and estimated hours:

5 Included support documents
Document name(s) Version

Minimum 5 years of related experience
Minimum Education: Bachelor's Degree