Mangan Biopharm offers personnel who can deliver specialty Life Sciences services, including GMP System commissioning, qualification & validation of facilities, utilities, equipment, and processes for the heavily-regulated Biopharmaceutical Industry.
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We offer automation and validation staff who are experts in their trades, consisting of a mix of former industry employees and consultants from around the country. Their breadth of industry experiences range from biopharmaceutical process R&D, manufacturing, plant design and startup, commissioning, validation, quality assurance, automation and control systems design, and implementation and management of capital projects.
After over twenty years of providing services to our clients, our personnel have the expertise to work with you on projects of all sizes. Regardless of project scope and size, Mangan Biopharm can provide expert professional services to deliver projects on time and on budget without sacrificing quality. Our clients become colleagues not opportunities.
With prior experience working for major pharmaceutical and biotechnology manufacturers in lead Engineering, Validation, and Quality roles, our highly trained personnel have successfully delivered GMP Systems commissioning, qualification, and validation projects for some of the largest pharmaceutical and biotechnology companies in the world.
What we Do
Policies & Procedures
With much experience at several biopharm clients, we can benchmark your validation program against current industry standards or create a new custom program that fits your unique business model.
Sometimes new products or new processes create a gap in your resources and you need a trusted partner who can provide professional services to help fill that short term need. Mangan Biopharm offers professional staff that have been instrumental in completing qualification projects in preparation for new product introductions at some of the largest biopharmaceutical companies in the world.
Change Control & Assessments
A critical component of a quality system is a robust change control process that incorporates a thorough risk assessment. Mangan can help you perform process and product impact assessments to ensure the integrity of your product lifecycle is maintained.
Mangan is a full service EPCM engineering company and has expertise in turnkey projects and can lead and implement projects from conceptual design phase through detailed design, procurement, construction, startup, commissioning, and qualification.
We have in-house expertise in Automation, Instrumentation, Electrical, and Structural engineering and are proficient with Rockwell Allen Bradley platforms and have done many small to complex projects with ControlLogix, CompactLogix, FactoryTalk SE/ME for the past 25 years. In addition, we have in-house capabilities with DeltaV DCS, Siemens SIMATIC controllers, and Intellution and Wonderware HMI’s. Mangan has alliances with electrical subcontractors and panel shops and can design, fabricate, install, and power-up your control panels.
SERVICES WE OFFER
Commissioning, Qualification and Validation Services
- Program Development
- Validation Master Planning
- Integrated Commissioning and Qualification (ICQ)
- Equipment Qualification (learn more)
- Validation Project Management
- Greenfield and Existing Facility Modifications
- FAT, SAT and Startup
- Sterilization (SIP, Autoclave, Terminal)
- Primary and Secondary Packaging
- Cleaning Validation (learn more)
- Process Validation (learn more)
- Computer Systems Validation (learn more)
- Cold Chain (Shipping Validation)
- Clean & Plant Utilities
- BMS, BAS, Data Historian, ERP/MRP & LIMS
- Automation and Control System Validation
Compliance and Quality Services
- Program / Procedure Development
- Regulatory Audits and Risk Assessment
- Regulator Audit Preparation & Management
- Facility and Systems Gap Analysis
- FMEA and Risk Assessments
- Failure Investigation Support and Review
- Regulatory Agency Audit Preparation
- Response Preparation
- Audit Observation Remediation
Contract Organization Support
- Surveillance Audits
- Regulatory Agency Observation Follow Up
- Program Review / Auditing
- Manufacturing Oversight (Customer Representation)
- Failure Investigation Support
- Cleaning and Process Validation Support
Automation and Integration Services
- Control System Integration
- Project Management
- System Design, Engineering and Fabrication
- System Lifecycle Documentation Development and Execution
- Plant Wide Historization and Management
- DCS/PLC/HMI Programming and Implementation
- S-88 Batch Programming
- IT/IS Planning, Configuration and Implementation
- Hardware / Software Platforms:
- Allen-Bradley/Rockwell Platforms
- BAS/BMS (Siemens, Rockwell, Honeywell)
- OSI Pi
- Additions and Modifications to existing facilities
- New construction
- Capitol Project Management
- Construction Project Management
- Scheduling and Resource Management
- Equipment Procurement
- FAT and SAT Support
“Mangan delivers on their projects with talented resources and the technical know how to offer solutions to problems instead of waiting on us to solve them. I appreciate their dedication and willingness to do what it takes.”
“We had some unexpected challenges that consumed our internal resources at the same time a critical project was in progress. Mangan stepped in and provided several validation engineers to fill the gap. Great job guys!”
“A trusted partner is often difficult to find. With Mangan, we have been pleased with their responsiveness and overall quality of their staff. What started as one small project has grown into a trusted partnership.. “