Engineering

Our Key Area of Life Science Services

psc bıotech

PSC Biotech® Engineering consultants assist life science companies in meeting regulatory compliance with CQV and more.

PSC Biotech® Engineers take a risk-based approach; thus, we always work with ICH Q9 guidelines in place. We have qualified and experienced engineers in over 35 countries to serve your new, existing, or decommissioning production site.

cGMP Engineering Services
Engineering Support
Engineering Drawings
Engineering SOPs
Redline Piping and Instrumentation Diagrams (P&IDs)
Support Preventative Maintenance Services
Equipment Commissioning, Qualification, and Validation
Software Validation
Metrology and Calibration
Serialization
Product Specifications
Hazard Analysis

Engineering Program Management
Certification Programs for Capital Projects
Lifecycle Management for Process, Facility, and Utility Systems
Program Management and Governance for engineering projects
Ensure compliance with Environmental Health and Safety (EH&S)
Technical Documentation and Writing – SOPs / LOTO Procedures / Global Harmonization / Risk Assessments
Training documentation creation and performing training
Design creation and review for early project stages (room classification, P&ID review, creation of review, etc.

psc bıotech

PSC Biotech® Industry Expertise

Cosmetics, Cannabis

Pharmaceuticals, Personalized Medicine

Medical Devices, Biotechnology

Tissue Products, Cell and Gene Therapy

Food & Beverages, Homeopathic, Nutraceuticals

PSC Biotech® Engineers work to your project needs. See our project success pages for examples. To start the process of gaining a PSC Biotech® Engineer to design, validate, implement, optimize, or otherwise assist in your engineering project, contact us today!

LIFE SCIENCE EXPERTISE ON DEMAND

What makes PSC Biotech® the partner of choice for leading life science companies? It’s our full-service approach to ensuring your facilities, equipment and processes meet regulations set by leading regulatory bodies. Access the full spectrum of software and service solutions your company needs to thrive. Contact a PSC expert today.

Contact our Experts

psc bıotech

Global Engineering Excellence for Life Sciences Compliance

We have qualified and experienced engineers in over 50 countries to serve your new, existing, or decommissioning production site. At PSC Biotech®, our Engineers focus on the engineering needs of pharmaceutical and medical device manufacturing in the life sciences. At the core, PSC Biotech® Engineers take a risk-based approach; thus, we always work with ICH Q9 guidelines in place. PSC Biotech® Engineers assist with cGMP FDA compliance, EMA compliance, MHRA compliance, and other regulatory standards as required.

Additionally, PSC Biotech® assigns a Project Manager to each Engineering project. The Project Manager utilizes our exclusively developed Project Tracker software to maintain an accurate and up-to-date deliverable document status. With years of expertise and regulatory awareness, our engineers execute projects in a highly efficient manner to meet your needs as soon as possible. See our project success pages for examples. Contact us for a customized assessment and cost estimate.

As an example of PSC Biotech® Engineer’s focus on Quality, Validation, and Documentation, here are some ways we’ve helped clients and what we can do for you:

21 CFR Part 211/210/820, ISO 13485, and FDA regulation compliance
Developing, amending, and implementing standard GMPs/SOPs
Implementing continuous improvements
Developing and improving production processes
Conducting complaint investigations and audits
Performing root cause analysis/NCRs for production
Resolving quality issues
Conducting engineering analyses

Sterilization – Autoclaves, Sterilization-In-Place (SIP), Clean-In-Place (CIP), freezers, Lyophilization Cabinets, Ointment Filler, and other Aseptic Equipment
Laboratory and Production equipment –Bioreactors, HPLCs, GCs, FTIR, ovens, filling machines, process mixers, process tanks, and freezers
Utilities – Electrical, Compressed Air, Nitrogen Systems, and HVAC
Drafting, editing, reviewing, and executing protocols

Compliance – cGMP, SOPs, batch records, validation documents
Reviewing 21 CFR Part 211/210/820, ISO 13485, and FDA regulation adherence
Functional specifications, systems designs, and process flow diagrams
Transferring existing protocols to new standard templates,
Developing new manufacturing processes and equipment technologies,
Designing and qualifying new processes
Developing training material
Creating test method protocols
Writing master validation plans
Master validation schedules

WHITEPAPER

Download Our Microbial Contamination Control White Paper

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CLIENT Testimonial

What Customers Are Saying

We Take Pride in the Relationships We Build and the Solutions We Provide

“A successful regulatory audit demands meticulous planning, defined roles, and effective communication. AuditUtopia® stands out as the most effective software tool for optimizing communication channels, enabling timely responses and evidence provision. It empowers the right resources within the organization to address auditor inquiries efficiently. With AuditUtopia®, I’ve navigated multiple intense audits with confidence and wouldn’t be without it.”

Steve Lawson

Senior Quality Assurance Engineer
Biomedical Manufacturer

“I am very happy with the services that PSC™ has provided. They have helped me here in San Diego and at our Madison site for many years now. They have provided highly-skilled validation specialists that have complemented our full time work force.”

Chris Brady

Manager, Facilities Engineering
Illumina

“Seasoned individuals are crucial for successful FDA inspections, managing various tasks seamlessly. AuditUtopia™ has proven its value in streamlining the inspection process, tested in simulated FDA mock inspections. As a former FDA investigator, I wholeheartedly endorse AuditUtopia® for regulated industries. Its efficiency will impress any FDA investigator, ensuring smooth inspection management—an essential bottom line.”

Jeff Yuen, MPH, MBA

Former Commander Food and Drug Administration

“This is to certify that PSC Biotech® (PSC™) has done a good job for our company in the range of auditing and consultancy. Their work was remarkably distinguished as auditors. As consultants, their work was successfully handled and enabled based on the level of expertise of their team in the U.S. and abroad.”

Angele Zaboura

General Manager
Beit Jala Pharmaceutical

“During the past year, our company has been working with PSC™ on various activities within the development and implementation of a new medical device product. PSC™ offers high quality services, and we can say that we have always been satisfied by their work.”

Sharon Fisher

Quality Manager
MicroGEM

“I cannot recommend anyone more highly than I recommend PSC™. They have been a god-send.”

Emerson Perin, MD, PhD

Quality Manager
MD Texas Heart Institute

“PSC™’s regulatory support was instrumental in overcoming a significant obstacle. Their independent approach, willingness to collaborate cross-functionally, and great communication eliminated the need for micromanagement. With minimal supervision, their expertise and connections exceeded expectations, making our success possible. Our relationship with PSC™ has been phenomenal, significantly easing my workload.”

Tiffanie Browne

Supply Chain Manager
Takeda

“I had the pleasure of collaborating with PSC™ for nearly two years on a critical validation project spanning Johnson and Johnson Surgical Vision sites globally. Their technical team developed comprehensive validation documentation and supported testing seamlessly. The project manager excelled in maintaining schedules, budgets, and providing guidance. PSC™’s professionalism and expertise fostered a highly efficient work environment, ensuring the project’s success.”

Victor Graham

QA Program Engineer III, Surgical
Johnson & Johnson Vision

how can we help you

Contact PSC Biotech Corporation Today!

Fields marked with an * are required

Engineering

psc bıotech

PSC Biotech® Engineering consultants assist life science companies in meeting regulatory compliance with CQV and more.

psc bıotech

PSC Biotech® Industry Expertise

Cosmetics, Cannabis

Pharmaceuticals, Personalized Medicine

Medical Devices, Biotechnology

Tissue Products, Cell and Gene Therapy

Food & Beverages, Homeopathic, Nutraceuticals

LIFE SCIENCE EXPERTISE ON DEMAND

psc bıotech

Global Engineering Excellence for Life Sciences Compliance

WHITEPAPER

Download Our Microbial Contamination Control White Paper

CLIENT Testimonial

What Customers Are Saying

how can we help you

Contact PSC Biotech Corporation Today!

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