Staff Augmentation Services - Manufacturing Technical Services
Pharma-Tech Process and Facilities Services, LLC provides engineering technical support services in support of virtually all aspects of biopharmaceutical manufacturing operations. Our project management and technical service personnel can identify efficiencies and engineering resource strategies to streamline Manufacturing Technical Services initiatives with a thorough understanding of complex biopharmaceutical manufacturing processes and a deep understanding of cross-functional organizations and quality systems. We specialize in project execution planning and implementation strategies for the technology transfer of traditional stainless steel unit operations consisting of P&IDs, Clean in Place and Steam Sterilization to the new world of single-use disposable technology with PFD’s, BOMs, gamma irradiation and leachable/extractables.
Pharma-Tech Manufacturing Technical Services capabilities include:
- Process and Facility Engineering and Technology
- Aseptic Processing
- MTS Subject Matter Expertise (SME)
- Project Management Best Practices
- Engineering Best Practices
- Organizational Development
- Cross-Functional Communication
- Operational Excellence
- Information Technology
- Owners Representation and oversight
- Technology Evaluation
- Cell Culture and Upstream Processing
- Purification and Downstream Processing
- Formulation and Fill Finish
- Technical Writing
- Design of Experiments
- Technology Transfer
- P&IDs, PFDs, DCFDs, Plan Drawings
- Engineering Evaluation
- Engineering Test Plans
- Manufacturing Support
- Equipment Ownership
- Change Control and Management
- Special Projects
- Media Challenge
- Single-Use Disposable Technology
- Material Specification and Certifications
- Bill of Materials
- Project Specifications
- Design Specifications
- Batch Records
- Production Troubleshooting
- Deviation Investigation and Closure
- Operational and Process Control Strategy
- Criticality and Impact Assessment
- Risk Assessment and Mitigation
- FDA 483 and Warning Letter Remediation
- Basis of Design (BOD)
- User Requirements Specifications
- Process Characterization and Validation
- Standard Operating Procedures (SOPs) and Guidelines
- On call support
- Training