Job Description:
Role Overview: The role reports into the ABC site Biologics BTS organization and provides technical and operational support to local and enterprise systems across the company. This role is responsible for MSI metrics, PVR’s(Periodic validation reviews, spreadsheet validation, collecting business requirements for technology improvements. This person will also collaborate with the team to ensure the smooth functioning of laboratory systems, instruments, and software, with a strong focus on compliance, data management, and process optimization in a GMP (Good Manufacturing Practice) environment.
Key Responsibilities:
• Support daily operations of QC laboratories, including troubleshooting issues with QC instruments and equipment.
• Assist with validation activities and documentation (including SIQ and SOQ protocols) to ensure regulatory compliance.
• Implement, maintain, and optimize excel macros and support spreadsheet validation for streamlined data processing and reporting.
• Coordinate and perform Windows upgrades, PC decommissions and software installations and upgrades for lab and operations computers.
• Provide technical support on eliminating manual processes and support feeding requirements to broader enterprise teams.
• Participate and evolve digital transformation by leveraging operations systems such as SAP, Infor, and MES systems (including POMS).
• Support process improvements and ensure data integrity across laboratory workflows.
• Perform Acronis and Nugenesis software installs on new lab PCs.
• Support the team with OSIPI data historian.
Required Skills & Qualifications:
• Experience working in GMP laboratory environments.
• Proficiency in Excel, including macro development and troubleshooting.
• Familiarity with validation processes, SIQ/SOQ documentation.
• Knowledge of QC laboratory instruments and equipment maintenance. Knowledge on windows upgrade, Nugenesis and Acronis.
• Hands-on experience with Windows operating systems and installations.
• Experience with operational software such as SAP, Infor, MES (e.g., POMS).
• Strong problem-solving, communication, and organizational skills.
Preferred:
• Background in life sciences or engineering.
• Previous experience supporting QC labs in pharma, biotech, or related industries.
This role is integral to ensuring QC labs and operations are compliant, efficient, and technically robust.
? functional areas and collaborates with key stakeholders.
Qualifications:
? Bachelor’s degree: Degree level qualification in computer science or equivalent relevant discipline [Senior] or respective proven expertise and experience
Cognitive/Business Skills:
? Requires a high level of attention to detail and mental concentration to always ensure accuracy and total compliance with procedures.
? Requires proven problem-solving skills and the ability to adapt to new requirements.
? Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
? Requires innovative thinking, where new and untested solutions are proposed, demonstrated, and implemented on a regular basis.
? Requires total commitment to quality and always maintaining a high standard of work.
? Always demonstrates the highest levels of integrity and a strong work ethic.
? Strong communication skills, both verbal and written, are required for the execution of this role.
? Strong interpersonal skills are required.
? Supports the principles of Perfect Performance.
? Apply advanced technical knowledge and experience to the solution of a broad array of technical problems.
Job/Technical Skills
? 3 years plus in IT QC System / Application Support (essential)
? 3 years plus of relevant IT experience (Essential)
? [Senior] 5 years plus of experience in similar / equivalent role within pharmaceutical industry
? ITIL (Essential)
? GAMP (essential)
? Project Management (Desirable), JIRA/agile knowledge
? Waters Empower (Desirable)
? AVEVA OSI PI Administration or relevant Data Historian Administration (Desirable)
? POMSnet Administration or relevant MES system Administration (Essential)
? Microsoft O365 PowerApps / PowerBi ( Essential)
? AWS/Microsoft certification
? Python/ JAVA skills or any software development and SDLC experience is a plus.
? SharePoint admin experience(Essential)
? Acronis and Nugenesis Knowledge( Essential)
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