EQUAL OPPORTUNITY EMPLOYER Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices. CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives. Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients. SUMMARY This position is responsible for maintaining a comprehensive IT-BS Validation Program for the qualification of manufacturing, lab, and business-based computer systems to remain in compliance with GMP Regulatory and IT-BS computer systems/data security expectations; specifically Annex 11 & 15. These services must align with FDA and EMEA Regulatory standards, be tailored to meet specific internal and/or client contract requirements and align with the IT-BS products/services of our parent company. ESSENTIAL DUTIES AND RESPONSIBILITIES Include the following. Other duties may be assigned. * Lead the Computer Systems Validation Program and activities as part of the overall IT-BS Department service for Corden Pharma * Close liaison with the building contractors, engineers, and vendors of the facility to ensure full and appropriate information is provided; along with vendor qualification protocols, as needed for a comprehensive IT-BS Validation Program * Implement and support IQ/OQ and technical qualifications as appropriate of Plant, Lab, and Business Computer Systems * Authorship and review of documentation; and advising team members on best practices * Lead training for compliance within CDMO Industry for IT-BS Group * Responsible for the execution and oversight of ongoing (DQ, IQ, OQ, PQ) validation activities * Review of vendor protocols and creation or approval of in-house protocols; and reports to deliver a complete package of qualification documentation * Responsible for the continuous improvement of computer system validation by improving efficiency and productivity * Responsible for timely authorship and routine review of SOPs and Quality documents in collaboration with IT-BS Management * As some validation activities will be outsourced, the role will maintain these vendor relationships, including monitoring KPIs so that performance and value for money is maintained * As a key service to the Quality Team, this role will contribute to the overall validation strategy for the site, as well as act as a technical point of contact for internal and external stakeholders * Responsible for internal and external audit response with respect to SME delegation for data integrity, CSV, CSQ, CSA, and general IT-BS topics * Key contributor for site project teams in the validation of IT-BS related computer systems; and equipment for all manufacturing, lab, and business areas working full-time on design, build and qualification activities, and improvements * Work effectively and supportively with other project team members to deliver on client needs within the GMP manufacturing facility, in accordance with the program and scope of work * Draft and review GMP documentation including validation documentation and training documentation * Demonstrate self-directed learning and obtain/maintain technical certifications as appropriate to the needs of a comprehensive computer validation professional * Understand the sites' production schedule and work closely with Manufacturing and Engineering to build an IT-BS Qualification Schedule that delivers minimum interruption to manufacturing output * Work in a safe manner, ensuring full compliance to SHE (Safety, Health, & Environment) policies * Participate in and respond to IT-BS System inspection requests by regulatory authorities and client audit teams representing the IT-BS functional group * Act as the primary point of contact for computer systems periodic reviews and practices, as required * Participate in continuous improvement of the manufacturing facility to enable production to be conducted effectively, efficiently, and within regulatory compliance * Establish and maintain strong relationships with cross-functional departments * Actively maintain and update knowledge and expertise of current developments, standards, and operating practices within the pharmaceutical industries * Interact with Leadership, Project Management, clients and team members to achieve project goals * Represent stakeholders, translate business needs and technical issues, and lead requirement reviews * Scope the requirements/capabilities of IT-BS Lab Computer Systems, elicit project requirements for lab system implementations - especially the business requirements * Write the project requirements in a clear, concise manner * Act as a communication broker - work with the project designers and architects to make sure their designs conform to the project and IT-BS validation requirements * Provide technical assistance and support for incoming queries and issues related to lab-related computer systems, networks, telecommunications, software, and hardware * Support the configuration, administration, and training on the IT-BS validation components of various lab computer systems, manufacturing instruments, and IT-BS business services * Respond to inquiries from staff, administrators, service providers, site personnel and outside vendors etc. to provide technical assistance and support, regarding IT-BS validation requirements and regulatory needs * Ask questions to determine nature of problem and walk customers and IT-BS staff through the IT-BS validation problem-solving process * Subject matter expert for the department and our customers; with integrated IT-BS validation solutions and procedures that will ensure proprietary/confidential data and computer systems are protected, and address data-integrity/regulatory standards and expectations * Responsible for oversight of periodic review of IT-BS systems (and participation where needed) * Responsible for oversight of preventative maintenance of IT-BS systems (and participation where needed) * Responsible for process ownership for site CSV activities (and corporate CSV where needed) * System ownership as appropriate * Responsible for participation in corporate IT-BS initiatives where needed LEADERSHIP & BUDGET RESPONSIBILITIES None. SAFETY & ENVIRONMENTAL RESPONSIBILITIES Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience. QUALITY RESPONSIBILITIES Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC's Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company. cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. To be considered for the role, candidates are to meet the following requirements: Required Skills * 8 years of experience working in a GMP licensed facility that includes aseptic and/or sterile manufacturing * Three years of experience in validation of new and legacy GMP manufacturing and laboratory equipment * Proven experience of managing compliance to GMP regulations and guidance, including specifically 21 CFR Part 11 and Annex 11 & 15 * Current working knowledge of GMP, with a deep understanding of validation within lab, manufacturing environments, and related equipment * Ability to work consistently and compliantly, following standard operating procedures and quality policies * Able to generate GMP documentation to a high standard and relating to validation, including policies, SOPs, protocols, and reports * Good communication skills; able to work with various team members across all functions * Good understanding of Quality Management Computer Systems; and having a controlled approach to identifying and reporting deviations, and completing CAPAs Preferred Skills * Experience in participating in the introduction of new processes and equipment into a GMP manufacturing facility * Previous knowledge and experience with Project Management including OPEX, Visual Management, and Six Sigma EDUCATION and/or EXPERIENCE Must have a Bachelor's Degree in a Computer or Life Science related field, such as Programming, Computer Science, Engineering, Lab Computer Systems, Network Security, or Infrastructure. LANGUAGE SKILLS Ability to read and understand common information technology technical literature. Ability to effectively communicate verbally and in writing with peers, customers, and management. MATHEMATICAL SKILLS Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, percent, and to draw and interpret bar graphs. REASONING ABILITY Ability to apply problem solving and best judgement to assigned tasks. CERTIFICATES, LICENSES, REGISTRATIONS None. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to stand; walk; work with hands; stoop, kneel, crouch, or crawl; and talk or hear. The employee is occasionally required to sit, reach above shoulder height, and climb or balance. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and noise typical of an office environment. CORE COMPETENCIES These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity. * Knowledge and ability applying problem solving, as demonstrated with schoolwork performance and work experience * Proficiency with the Microsoft Office Suite, Visual Basic, and SQL Scripting * Senior knowledge of computer Infrastructure Computer Systems (software and hardware) * Senior knowledge of instrumental analysis applications and analytical chemistry * Basic Active Directory administration experience * Familiarity with virtualization software, i.e., VMWare * Knowledge and experience with Windows XP/Windows 7/Windows 10 * Familiarity with a networked client-server and/or Virtualized Computer System environment (e.g., TCP/IP, DNS, DHCP, etc.) * Analytical and troubleshooting skills * Ability to handle multiple tasks simultaneously * Excellent customer service and communication skills * Must be a team player and have the ability to multi-task * Project management skills * Willingness to learn new technologies SALARY Actual pay will be based on your skills and experience. BENEFITS * 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service * Accident Plan * Critical Illness Insurance * Dental Insurance * Disability Insurance * Employee Assistance Program * Flexible Spending Account * Health Insurance PPO/HSA * Hospital Indemnity Plan * ID Theft Protection * Life Insurance * Paid Maternity/Paternity Leave * Tuition Reimbursement * Wellness Program * Vacation - Three Weeks 1st Year * Vision Insurance This post will expire on June 4, 2025