Erik Kopp Email & Phone Number

2500 Valby, Dk

Support laboratory instrumentation integration with lab e-Systems (LIMS, ELN) to optimize efficiency of laboratory workflows through enhanced automation. Coordinate integration of new and existing laboratory equipment with commercially available and proprietary software. Provide technical, change management and validation support of automation platforms. Create and maintain applicable procedures and work instructions to support system users.

Manage company website / blog. Publish decomplexified instructional and informational products for small businesses and individuals.

Princeton, New Jersey, Us

Remotely manage a team of engineers and documentation analysts to support manufacturing operations. Successfully implemented a hybrid remote/onsite strategy to ensure optimum product yields and process efficiency with no interruptions.Increased yield of key products by 30% through continuous improvement program for manufacturing and overseeing deep dive project to reduce costs and optimize compliance, thereby reducing scrap.Achieved cost savings of over 20% Creating and managing controlled documents (Standard Operating Procedures, Work Instructions, Forms, Specifications) and training of stakeholders to ensure compliance and optimize process efficiency.Eliminated backorder on product needed for lifesaving surgery through root cause analysis and problem solving to investigate nonconformances (NC) and implement Corrective/Preventive Actions (CAPA).

Morristown, New Jersey, Us

Perform validation (IQ, OQ, PQ) of process equipment and utilities for medical device production.• Create validation protocols.• Execute validation studies.• Manage GMP documentation.

London, England, Gb

Eliminated GMP/regulatory compliance risks and enhanced market penetration through standardized labeling production and management processes globally for all regulated medical device product labeling and associated documentation; specifications, work instructions and standard operating procedures (SOP).Reduced labeling development cycle time by more than 50% through process optimization and implementation of an automated online system to manage labeling artwork.

New York, New York, Us

Successfully integrated multiple acquired organizations into unified laboratory data processes and implemented a new centralized Laboratory Information Management System (LIMS), Chromatography Data System (CDS) and calibration system to provide globally accessible data to the integrated organization in a consistent format.Created, revised and maintained documentation required for R&D operations and regulatory compliance to support integration of multiple organizations. Includes standard operating procedures (SOP), Work Instructions, Product Specifications, Validation Protocols, Technical Reports, User Requirements (URS) and Functional Requirement Specifications (FRS). Created, validated and implemented Business Continuity Plan (BCP) for Pfizer Consumer Healthcare R&D to mitigate financial risk due to unplanned business interruption and ensure compliance with Sarbanes Oxley (SOX) regulations.

Bachelor Of Engineering (Beng), Chemical Engineering

Master Of Business Administration - Mba, Business Administration And Management