PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.Job Title: IT Systems Analyst, GMP Systems

Role:

The IT Systems Analyst, GMP Systems will be supporting GMP critical systems within the Manufacturing and/or Laboratory environments of manufacturing sites. The candidate will have strong technical skills working in GMP regulatory requirements.

Responsibilities

• System Owner for Manufacturing IT Applications and/or QC Analytics systems in a 24x7 Good Manufacturing Practice (GMP) environment.
• Work with the Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
• Perform system administration, support/troubleshooting, and lifecycle management activities for supported systems.
• Work to identify opportunities to create additional value and improve business processes, compliance, and maximize the benefits of standardization of technologies and leverage across sites.
• Assist with system validation and lifecycle management processes.
• Determine business criticality and product quality requirements, ensure appropriate service levels, Disaster Recovery procedures, governance, change management, compliance, and operational support.
• Lead or coordinate technical discussions and vendor negotiations.
• Support regulatory audits as needed.

Qualifications:Has business domain knowledge in the following areas:

• Biopharmaceutical or similar Manufacturing domain.
• Experience as a System Owner for validated GxP Systems.
• Familiar with Data Integrity methodologies.
• Experience writing Standard Operating Procedures (SOPs).
• Basic understanding of Computer Systems Validation.
• Basic knowledge of Manufacturing Execution Systems, Distributed Control Systems (DeltaV), LIMS, Data Historian, ERP etc.
• Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles.

Requirements

• Bachelor’s Degree in Information Technologies, Engineering, Sciences or equivalent experiences.
• 3 years of experience implementing and managing GxP computer systems in the manufacturing or laboratory domains.

EEOC StatementAt PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.Thank you for your consideration and application! We review all resumes and submissions, however, due to the sheer volume of requests we receive, only successful candidates will be contacted.