Manufacturing Associate II

Immediate need for a talented Manufacturing Associate II . This is a 12+ months contract opportunity with long-term potential and is located in Swiftwater, PA (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 26-09746

Pay Range: $27 - $29/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• TECHNICAL TASKS AND DELIVERABLES / SCOPE
• The Continuous Improvement Contractor will execute the following activities and responsibilities:
• 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:
• Quality Control
• Manufacturing Science and Technology (MSAT)
• Sterility Assurance
• Engineering
• Operations
• Quality Assurance
• 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
• Technical Support and Process Improvement
• Provide technical support for:
• Component qualification activities
• Overall Equipment Effectiveness (OEE) improvement initiatives
• Electronic Batch Record (eBR) implementation and optimization
• Opstrakker system utilization
• General factory improvement projects
• Facilitate resolution of unresolved issues and deliverables by:
• Leading cross-functional meetings
• Positively influencing functional managers
• Removing obstacles and barriers to progress
• Managing projects and competing priorities effectively
• 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
• 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
• Professional Development
• Proactively identify opportunities for professional growth and development
• Stay current with applicable sciences and methodologies that enhance team capabilities
• Contribute to knowledge sharing and team skill development

Key Requirements and Technology Experience: 

• Key skills: - Continuous Improvement professional with 3–5 years of experience in pharmaceutical manufacturing and strong knowledge of cGMP environments, particularly in formulation and filling operations.
• Ideal candidates will have handson experience managing CAPA and Change Control activities, authoring technical documentation, and supporting crossfunctional teams including Quality, MSAT, Engineering, Operations, and Sterility Assurance.
• They should bring expertise in Lean/Six Sigma methodologies, equipment qualification, OEE improvement, and electronic systems such as eBR, Opstrakker, and Qualipso.
• Strong candidates excel in communication, technical writing, project management, and influencing across teams.
• Proficiency with Microsoft Office and familiarity with ERP systems (iShift preferred) are important. Candidates must be adaptable, detailoriented, and capable of driving continuous improvement in a fastpaced, regulated environment.Experience: 3-5 years experience in technical documentation and cGMP systems.
• Manufacturing Operations: Deep understanding of cGMPs and pharmaceutical manufacturing activities, including:
• Formulation processes
• Filling operations
• Lyophilization (freeze-drying) processes
• Continuous Improvement Methodologies:
• Comprehensive knowledge of Lean Manufacturing concepts and principles
• 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
• 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
• 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

Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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