Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Position Summary
As a member of the PSG IT Ops and Services Team, you will contribute to delivering reliable application solutions and providing application support for the site. This will be done in partnership with other global IT functions.
What will you do?
- Deliver Business systems support services in support of business objectives to maintain operational stability and improve productivity and efficiency.
- Understand and analyze existing business processes, identify gaps between systems and user processes, find issues and opportunities for continuous improvement.
- Serve as an internal technology expert and assist with identifying and developing new emerging technologies and solutions.
- Support testing, user acceptance, and training phases, ensuring successful project rollout and user happiness.
- Ensure availability of critical business applications (e.g., SAP, Sample Manager, Chromeleon, Maximo, Trackwise, Ariba) and support business for daily usage, improvements, user management, etc.
- Partner with Global and Site Quality teams to ensure adherence to Data Integrity and Computer Validation standards. Responsibilities include tasks such as generating, reviewing, approving, and maintaining departmental documentation like user and design requirements, procedures, IQ/OQ/PQ, and system reports.
- Perform periodic system reviews such as audit trail and user access reviews.
- Work and coordinate with global and local IT Teams and vendors to review and resolve system issues.
- Monitor interfaces to ensure alignment between systems (e.g., SAP, Blackline, Maximo, Trackwise).
- Coordinate IT projects with global IT teams (e.g., Pharma 4.0 initiatives, business systems upgrades).
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Experience
- Bachelor's degree in Information Technology, Computer Science or equivalent.
- 5+ years of work experience in IT business applications management and support in a fast-paced manufacturing or distribution operations MNC company environment, including 2 years of experience in project management.
- Prior experience with Good Manufacturing Practices (GMP) and Computer System Validation (CSV), preferably within the pharmaceutical industry is a strong plus.
- Prior experience with GxP systems (e.g., SAP, Trackwise, Maximo, Chromeleon, Empower, LIMS) support and ServiceNow is preferred.
Knowledge, Skills, Abilities
- Strong Business Insight and analytical skills, ability to understand and interpret business issues and requirements and translate them into innovative and efficient solutions.
- Good understanding of Systems Development Life Cycle (SDLC).
- Familiar with the latest advancements in new technologies (e.g. AI and Cloud Computing).
- Strong problem-solving and root cause analysis capabilities to identify underlying causes of system issues, enabling effective resolution and prevention.
- Proficiency in crafting clear and comprehensive documentation for technical and non-technical users.
- Computer Software Validation (CSV) knowledge in industry practices (e.g., GAMP 5 and ISPE) and FDA and European regulations.
- Ability to clearly explain technical concepts to audiences with varying levels of technical knowledge.
- Foster continuous learning, supporting a positive and productive work environment.
- Excellent verbal and written communication skills in English.
- Able to work in a team-oriented and collaborative workplace.