Michael Merz, Csqe, Cpip Email & Phone Number

Collegeville, Pa, Us

Newark, Delaware, Us

Retired from full-time work for now, may come back for the right opportunity

Radnor, Pa, Us

Hanover, Md, Us

Drawing from my extensive experience to oversee the performance of various programs including Validation, Calibration, and Preventative Maintenance providing strategic direction and comprehensive leadership. Write, analyze, and approve validation documents ensuring adherence to internal and external regulatory requirements and quality standards. Held accountable for the creation and review of Site Validation Master Plans, Master Equipment lists, and SOP's associated with equipment and computer system validation. Develop, review, and implement IQ/OQ/PQ protocols for GMP and laboratory equipment as well as process control instruments for HVAC systems. Cultivate critical relationships with vendors. Conduct calibrations on various instruments. Key accomplishments include:• Championed efforts to align processes with the Data Integrity requirements of FDA 21CFR Part 11 and EU Annex 11, identifying gaps and executing remediation strategies. • Enabled the expansion of storage and testing space by qualifying the GMP expansion project in 2016. • Selected to lead the committee in determining requirements for qualification of a GMP facility forecasted to expand manufacturing capacity. • Spearheaded the redesign and establishment of a Computer System Validation program encompassing CSV Change Control, CSV Master Process, Validation Planning, System Requirements Specification, System Design and Configuration Specification, Testing Process and Documentation, Spreadsheet Qualification, CSV Training, System Commissioning Memo, Validation Summary Report, Leveraging Validation Project Deliverables, Data Migration, QA Audit of CSV Deliverables, and Computer System Decommissioning• Key contributor in the successful building renovation by providing strategic leadership of the design, permitting, vendor selection, and related projects

Establishment of validation standards, development of testing protocols, preparation of equipment, documentation of test results and maintenance of records for later analysis. Coordination with other personnel or departments who are affected by validation activities. Composition of reports and making adjustments to equipment or processes that require improvement. Performing periodical testing and monitor utilities including HVAC, CCA, Nitrogen and Deionized Water systems. Other duties include preventative maintenance, maintenance of testing equipment and overseeing the inventory of validation supplies. Management of the Calibration and Preventative Maintenance (PM) Programs, ensuring adherence to the applicable program schedules and also providing vendor oversight for calibration and preventive maintenance activities.Essential Duties and Responsibilities:• Writes, reviews and/or approves validation documents ensuring the documentation meets regulatory requirements and quality standards. • Managing the Validation, Calibration, and Preventative Maintenance Programs. • Writes, reviews and executes IQ/OQ/PQ protocols for GMP equipment, laboratory equipment and instrumentation and utilities and corresponding Summary Reports. • Aids in the management of building improvements/renovations including; design, permitting, vendor selections, and managing projects. • Reviewing equipment and utilities to determine if revalidation is required per procedural requirements. • Manages calibration and maintenance activities with vendors for equipment and utilities on a monthly basis. • Facilitates routine calibration on instruments, such as stopwatches and thermometers. • Monitors Prism on a daily basis to ensure proper operation of HVAC units in the GMP Area.

Supported IT/QA management in the establishment of an FDA compliant computer systems development lifecycle (SDLC) based validation program using risk management and GAMP V as the basis. Collaborated cross-functionally to identify and resolve issues. Developed validation documents to accompany new and existing processes and equipment. Served as a subject matter expert in the performance of validation upgrades, integrations, and policy implementation. Key accomplishments include: • Successfully provided qualification and administration of the Master Control Electronic Document Management System. • Validated the design of a web-based on-demand labeling system for remote contract packaging facility utilization. • Entrusted to lead FDA regulatory filing efforts as an electronic signature company. • Instrumental in the upgrade to the EDMS system (Master Control) leading validation efforts as well as serving as the system co-administrator.

Provided expertise and management of CSV program implementation and alignment with GAMP principles. Responsible for ensuring that departments involved in the manufacture, testing and distribution of product comply with validation requirements and procedures designed to maintain the product quality requirements. Provided guidance for writing, reviewing and approving computer validation documents (URS, VMP, FRS, DDS, RA, Vendor Audits, IQ, OQ, PQ, and Summary Reports) for a diagnostic medical device manufacturing facility. Wrote Computer, Process and Facility VMP's, ERP system validation lifecycle documents.

Hanover, Md, Us

Enlisted by this Computer Systems Validation consulting group to provide CSV services for Wyeth Research (now Pfizer) in Collegeville, PA. Interaction with project managers and code writers and troubleshooting of protocol problems; writing and executing of test scripts for an electronic document management system (EDMS). Revision of docbase object descriptions and property docbases, computer based training and testing materials.

Recruited by this pharmaceutical and biotechnology consulting group to provide validation consulting services for Merck, Centocor, and Amgen. Interacting with project managers, reporting project progress and resolving process problems; producing long-term process limits for analytical testing parameters and developing temperature mapping of controlled environment units.Drove completion of all project objectives, operating 20% ahead of anticipated schedule despite numerous scope expansions.Executed trend analysis macro that established Long-Term Statistical Process Control Limits for Biological and Sterile Pharmaceutical products through compilation of annual review data.Developed and implemented trend analysis protocol for BTMC Building Automation System.

Brought in to write and execute validation protocols for this pharmaceutical and biotechnology consulting provider. Responsible for preparing and executing validation protocols for pharmaceutical and biotechnical facilities; met with customers to determine appropriate resolution to deviations.Successfully led Aventis quality control project that required qualification of 50 instruments to meet GMP compliance requirements for upcoming FDA pre-approval inspection.Assisted in the continuation of valuable research work for New Jersey public health agency through autoclave cycle development to ensure sterilization of loads according to content.Qualified 14 HPLC systems at GSK to maintain compliance in the production of a new Penicillin product.

Joined this burgeoning pharmaceutical and biotechnology consulting firm offering validation services to write and execute validation protocols. Daily responsibilities included meeting with customers (McNeil Consumer Products, Baxter Healthcare) to discuss resolution of deviations and protocol execution requirements. Wrote and executed IQ/OQ/PQ for pharmaceutical products, coatings, TK Fielder Granulator, York Chiller, cleaning solution changeover, Tote bulk transfer system and various other validation projects. Hands-on validation experience with many solid dose manufacturing systemsTrained to write & execute cleaning validation protocols and sample analysis by HPLCParticipated in the development of a video training module that standardized manufacturing process for the purpose of achieving job performance consistency.

Selected to perform physical and chemical testing for the world's largest producer of pharmaceutical products. Job entailed testing for quality of products, intermediates and raw materials; utilized LIMS and PCs to interface data. Maintained, calibrated and validated laboratory instruments and equipment.Proficient in wet chemistry, FTIR, UV, AA, Fluorescence Spectroscopy, Karl Fisher titration, GC, HPLC, dissolution and robotic operations that aid in the determination of the quality and stability of products.

Bachelor'S, Chemical Engineering

Graduate Certificate, Pharmaceutical Manufacturing

Chemical Engineering