Commissioning & Qualification Consultant
James is a seasoned Process Engineer with two decades of expertise in the pharmaceutical industry. He excels in upstream/downstream processes, fill/finish operations, and utilities. His background encompasses a robust mix of IT, technical, and QA/validation knowledge, augmented by exceptional organizational and leadership capabilities.Â
At Commqual Solutions, James brings a wealth of experience from previous roles at prestigious companies such as PharmChem Technologies, Biogen, Eli Lilly & Company, and more. His global project experience includes leading commissioning and qualification (C&Q) efforts and process engineering for high-profile biopharmaceutical projects across various countries.
Currently, James serves as the Process C&Q Lead for ABEC Equipment and Documentation at WuXi Biopharmaceuticals in Dundalk, Ireland. Here, he develops execution strategies, manages documentation, and ensures quality compliance in a state-of-the-art manufacturing facility. His role involves strategic planning, protocol development, and mentoring junior engineers, highlighting his ability to drive project success through meticulous attention to detail and innovative solutions.
James's technical proficiency spans control systems like DeltaV DCS, FactoryTalk, SCADA, and ABB 800XA, and he is adept with C&Q software packages such as Kneat. His career is distinguished by his commitment to excellence, innovative approach, and successful leadership of diverse engineering teams, making him a pivotal asset to Commqual Solutions and the pharmaceutical engineering field.
CPA
Jessica has recently taken on the role of Owner and Operations Manager at Commqual Solutions LLC, a consultancy specializing in Commissioning & Qualification (C&Q) for the pharmaceutical industry. With a robust background in tax, accounting, and financial management, Jessica oversees operations, financials, and the strategic direction of the company. Her credentials include qualifications as an Associate of the Institute of Taxation Ireland (AITI, 2009), Certified Public Accountant (CPA, 2007), and Institute of Accounting Technicians Ireland (IATI, 2003).
Jessica's previous roles have honed her skills in managing complex financial and tax matters, ensuring compliance, and providing strategic financial insights. Before joining Commqual Solutions, she was a Tax & Accounting Consultant, managing client books, prepared financial statements, and provided tax advice. She also held various positions such as Financial Analyst and Financial Accountant.
In her role at Commqual Solutions, Jessica collaborates closely with her husband, who is a process engineer leading pharmaceutical projects and training initiatives. Together, they blend their expertise in finance, operations, and engineering to ensure the consultancy delivers high-quality services and achieves client satisfaction in the pharmaceutical sector. Jessica's leadership and financial acumen are pivotal to the success and growth of Commqual Solutions.