Systems Analyst II

Job Description

Overview

The role reports to the Associate Director of Global Service Delivery and will be responsible for a broad range of tasks including application support, enhancements, implementation projects and maintenance, ensuring that businesses processes and supporting systems continue to meet business needs.

Responsibilities

• Responsible for completing scheduled administrative tasks on Manufacturing Equipment and Applications including MES/ MCS / OSI PI and Serialized platforms.
• Provide technical support for control systems, MES/ MCS/ OSI PI and Serialization platforms to Engineering, Validation, Maintenance and Process Engineers across Manufacturing and Process Development as required.
• Proactively identify opportunities, anticipates problems, and implement solutions with the Process Automation Engineers, Process Engineers, Manufacturing Associates, and the Maintenance team as required for business impacting issues.
• Records and investigates issues, performs root cause analysis, escalates to management and other teams as required. Co-ordinates the response with external vendors for issue resolution, upgrades etc.
• Aim to resolve 90% of break / fix issues locally with the Global User Network.
• Escalate more complex issues to management / 3rd level support as required.
• Assist in co-ordination and management of manufacturing system related projects works with vendors, engineering project managers and business users to maintain systems to the required standards.
• Fosters collaborative relationships within and across groups and uses effective influencing and negotiation skills with key stakeholders, including vendors, customers, and solution providers.
• Liaise and communicate with site users and vendors to ensure manufacturing systems operate to maximum effect, and as per the IT Strategy
• Apply knowledge and support for 21CFR part 11 and Good Manufacturing Practices
• Maintain specifications, protocols, procedures, and other documentation as required. Keep documentation current as per site good documentation and data integrity practices (drawings, specifications, validation documentation etc)
• Perform support (with some after hour on-call), change control, and applicable maintenance of above systems.
• Demonstrates the ability to operate in a culture of efficiency, helpfulness, innovation, continuous improvement, enthusiasm, reliable & consistent delivery, integrity, partnership, and collaboration, locally and globally.
• Act as an agent for process optimization to reduce downtime.
• Act as an agent in the adherence, adaptions, and development of IT standards.

Qualifications

• Bachelor's degree preferred (Engineering or Computer Science), or degree in process, with experience on manufacturing systems, IT standards and Data management and acquisition.
• 5+ years IT applications experience including extensive knowledge and expertise in application lifecycle management with specific focus providing support for key applications supporting manufacturing operations.

Knowledge/Skills what would be of benefit in role.

• Experience with OSI PI Historian or similar data historian a plus
• Experience with serialization systems and associated vision systems a plus Fosters collaborative relationships within and across groups and uses effective influencing and negotiation skills with senior level management and key stakeholders.
• Previous experience in the biotechnology / pharmaceutical industries and implementing Computerized systems in a GMP environment.
• Excellent analytical problem solver
• Experience in the use of Seavision Serialization platform
• Experience in the use of PAS-x the Werum eBR platform
• Knowledge in Triaging of support call and ticket management
• Demonstrated track record of administration and support of manufacturing platforms
• Experience with full software development life cycle in regulated environment (FDA, GxP, HIPAA, SOX, GDPR and other data privacy, computer system validation, a plus)
• PLC and HMI SCADA experience a plus based on Siemens and Allen Bradley platform.

Personal Attributes:

• Results oriented.
• Excellent communication and stakeholder engagement skills; within team and with other departments.
• Excellent organizational, scheduling, and documentation skills.
• Independently manage and prioritize workload.
• Act as a role model, particularly in difficult situations.
• Ability to react quickly to understand and solve problems.
• Ability to provide clarity to others in ambiguous situations.
• Positive management attitude; team player.
• Understands and promotes company objectives.
• Strong sense of ownership and responsibility.
• Strong communication and presentation skills.
• Effective risk analysis and stakeholder facilitation to reach timely decisions.
• Strong conflict management and prioritization skills.

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About Us

Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.