Freeman Contracting and Consulting LLC is a veteran owned company that has been in business for 10 years, providing high quality CQV execution and project life cycle support services for FDA regulated facilities from the Carolinas to California. Employing on-site, hybrid, and remote strategies our diverse team of energetic Engineers and Project Management professionals provide the following support services to FDA regulated facilities: ? Commissioning, Qualification and Validation (CQV) ? Project Management ? Staff Augmentation (Quality, Engineering, Automation, Calibration)
Freeman Contracting and Consulting LLC的外部链接
US，North Carolina，Greensboro，27406
Freeman Contracting and Consulting LLC转发了
Exciting news! The 2025 ISPE Tech Show is happening at the Raleigh Convention Center on February 25th. While our booths are officially sold out, attendee tickets are still available. Don’t miss out on this opportunity to connect, learn, and explore the latest in tech. See you there! #25techshow
OPEN for New Contract: Contract Engineer | Validation & CQV Expert with Extensive experience in FDA-regulated pharmaceutical and medical device industries, specializing in process optimization, validation, and compliance. Availability: Immediate Education: Master of Science: Mechanical Engineering Bachelor of Technology: Mechanical Engineering Certifications: Project Management Professional CATIA v5, AUTOCAD, Tableau, LEAN SIX SIGMA GB/BB Industry & Client Experience: - Validation & CQV: Commissioning, qualification, and validation (SAT, IQ, OQ, IOV). - Process Optimization & Quality Assurance: Lean methodologies, CAPAs, change management, risk mitigation. - SOP Development & Technical Writing: Creation and refinement of controlled documents, regulatory submissions, and compliance reports. - Client Experience: Pfizer | Thermo Fisher Scientific | FujiFilm Diosynth | Biogen | Baxter International Equipment & Software Proficiency: - Bioreactors | Clean Steam Generators | HVAC | Buffer Prep Tanks - Vial/Syringe Fill Lines | Isolators Tangential Flow Filtration (TFF) | - Steam-in-Place (SIP) | uHPLC | UV Spectrometer | Endotoxin Plate - TrackWise | Veeva Vault | LIMS | QMS | PLM | SAP | DeltaV | AutoCAD - BIM360 | Smartsheet | Primavera | Microsoft Office | Minitab | Tableau Results-driven, problem solver, and expert in validation, compliance, and process optimization. Looking for Expertise? Contact us today to connect and discuss how this contract engineer's expertise can support your business! https://lnkd.in/dVSZxX6M #ValidationEngineer #CQV #Biopharma #Biotech #RegulatoryCompliance #GMP #GLP #TechnicalWriting #SOPDevelopment #ProcessValidation #PharmaceuticalIndustry #AsepticProcessing #Commissioning #Qualification #ContractEngineer
OPEN for new Contract: Validation Engineer | Technical Writer with extensive experience in biopharmaceutical and biotech industries, regulatory compliance, and validation processes. Availability: Immediate Education: Civil Engineering Certifications: Team Client and Brand Management Certificate Program and Project Management (PPM) Professional Services Automation (PSA) DNV Business Assurance; Gowning Qualification and Personnel Monitoring; ISO 45001:2018, Bio works and Lyophilization certification Lean Six Sigma Green Belt (in progress); Python Programming, Lean Machine Industry & Client Experience: - Validation & CQV: Commissioning, qualification, and validation of facilities, utilities, and process equipment. - Compliance & Regulatory Affairs: FDA compliance, GMP, GLP, cGMP, SOP development, regulatory audits, and risk assessment. - Technical Writing & Documentation: Creation and revision of technical documents, SOPs, validation lifecycle documents, and regulatory submissions. - Aseptic Processing & Contamination Control Client Experience: Pfizer, Thermo Fisher, Glenmark, and other leading biotech & pharma companies. Equipment & Software Proficiency: -Spectrophotometry | Chromatography | TLC | Weighing Balance Calibration | -Kaye Validators | USP - Pyrogen & Endotoxin Testing | Microsoft Office Suite -SharePoint | CMMS | TrackWise Fluent in English, Arabic, and French. Proven leader, problem solver, and expert in validation and regulatory compliance. Looking for Expertise? Contact us today to connect and discuss how this contract engineer's expertise can support your business! https://lnkd.in/dVSZxX6M #ValidationEngineer #CQV #Biopharma #Biotech #RegulatoryCompliance #GMP #GLP #TechnicalWriting #SOPDevelopment #LeanSixSigma #ProcessValidation #PharmaceuticalIndustry #AsepticProcessing #Commissioning #Qualification #ContractEngineer
Good Documentation Practices (GDP) in Biopharma: Ensuring Compliance & Quality In the biopharma industry, Good Documentation Practices (GDP) are essential to ensuring product integrity, regulatory compliance, and patient safety. Proper GDP safeguards the accuracy, reliability, and traceability of critical data throughout the drug development and manufacturing lifecycle. Why is GDP Crucial in Biopharma? - Ensures data integrity and regulatory compliance with agencies like the FDA, EMA, and MHRA - Minimizes risks of errors, deviations, and batch failures in manufacturing and quality control - Supports audit readiness by maintaining accurate, complete, and retrievable records - Strengthens cross-functional collaboration between QA, CQV, and regulatory teams Key GDP Principles in Biopharma: - Legibility & Accuracy: All records must be clear, readable, and error free - Traceability & Attribution: Every entry must be signed, dated, and linked to the responsible person - Real-Time Documentation: Data should be recorded at the time of the activity to prevent gaps - Compliance with ALCOA+ Standards: All data should be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available. At Freeman Contracting and Consulting (FCC), we help biopharma companies implement GDP best practices to enhance regulatory compliance, streamline operations, and mitigate risks. Let’s Work Together to Strengthen GDP in Biopharma! Contact us to learn how FCC can support your documentation and compliance needs. https://lnkd.in/dVSZxX6M #Biopharma #GoodDocumentationPractices #GDP #DataIntegrity #Compliance #CQV #RegulatoryCompliance #QualityAssurance #OperationalExcellence #ALCOA
OPEN for new Contract: Contract Engineer with 3 years of industry experience in FDA-regulated pharmaceutical and medical device companies. Availability: Immediate Industry & Client Experience: - Validation & CQV Engineering: SAT, IQ, OQ, IOV Commissioning - SOP Development & Technical Writing - Client Experience: Pfizer | Thermo Fisher Scientific Equipment & Software Proficiency: - Filling Lines | HVAC Systems | Sterile BPE Equipment - Microsoft Office Suite | Documentum Great communicator, self-starter Looking for Expertise? Contact us today to connect and discuss how this contract engineer's expertise can support your business! https://lnkd.in/dVSZxX6M #ValidationEngineering #PharmaceuticalIndustry #CQV #FDACompliance #ProcessOptimization #QualityAssurance #TechnicalWriting #EngineeringExcellence
?? How Generative AI is Transforming the Pharmaceutical Industry Imagine a future where drug discovery takes half the time, clinical trials are more efficient, and treatments are tailored to individual patients. That future is now powered by Generative AI. ?? The Impact in Numbers: ?? $60–$110 billion in annual potential unlocked for pharma and medical products. ?? Drug discovery timelines cut in half, accelerating life-saving treatments. ?? 20% boost in clinical trial efficiency, leading to faster regulatory approvals and reduced costs. ?? AI tools like AlphaFold2, BioGPT, and Med-PaLM are leading this revolution, reshaping disease understanding and drug development. But AI alone isn’t enough—real transformation requires action: ? Robust data infrastructure to unlock AI-driven insights. ? Change management for seamless AI integration. ? Regulatory foresight to protect data, privacy, and intellectual property. Think about electricity in the 1900s—it didn’t just power factories; it redefined industries. Generative AI holds the same potential for healthcare and pharmaceuticals, but only for organizations ready to adapt, innovate, and lead. How do you see AI shaping the future of pharma? Let’s discuss in the comments! ?? #GenerativeAI #PharmaTech #BiotechInnovation #FutureOfMedicine #AITransformation
Good Engineering Practices (GEPs): The Foundation of Excellence in FDA-Regulated Projects ?? In the fast-paced world of FDA-regulated industries, Good Engineering Practices (GEPs) often work behind the scenes, ensuring quality, compliance, and innovation at every stage of a project. At Freeman Contracting and Consulting LLC (FCC), we recognize the power of GEPs to transform biopharmaceutical and life sciences projects. From initial design to final commissioning, GEPs provide the structured approach needed to achieve operational excellence. Here’s why GEPs matter: ?? Regulatory Alignment: Ensures compliance with cGMP and global quality standards. ?? Project Control: Facilitates change management, cross-disciplinary reviews, and stakeholder engagement. ?? Traceability: Documents every step of the process, ensuring reliability and audit readiness. ?? Sustainability & Safety: Incorporates environmental impact, ergonomics, and HAZOP analysis for sustainable and safe operations. By leveraging GEPs, organizations can strike the perfect balance between efficiency, compliance, and innovation—delivering high-quality outcomes while meeting strict regulatory demands. GEPs in Action: ?? See the chart below to understand how GEPs streamline processes across project lifecycles, from design and procurement to commissioning and validation. ? Let’s Move the Industry Forward Together! ? At FCC, we’ve partnered with leading companies to design, execute, and validate projects that adhere to GEP and FDA requirements. Whether you're planning a new facility or upgrading existing systems, we’re here to help. ? ?? What are your biggest challenges in implementing GEPs? Share your thoughts and let’s discuss how we can tackle them together. #GoodEngineeringPractices #GEP #FDACompliance #Biopharma #OperationalExcellence #ProjectManagement
Freeman Contracting and Consulting LLC转发了
It's the most wonderful time of the year for a Therapeutic Thursday at Splitsville in Tampa - Thursday, December 5th from 4-7pm. Thank you to our gracious sponsors Hodess Cleanrooms, The Full Lifecycle Partner and @PCI cleanroom contracting for sponsoring and giving us the opportunity to give back to Marine Toys for Tots Foundation! register below and see you there!
Freeman Contracting and Consulting LLC转发了
Join us for an evening of fun and opportunity to share your business with the community. Business sponsors will have a moment to “spotlight” their businesses. Don’t miss out, it’s going to be a blast!