Manufacturing Systems & Process Support Specialist

Alkermes • Wilmington, OH

2d

About The Position

The Manufacturing Systems and Process Support Specialist supports key manufacturing systems and processes to ensure compliance, efficiency, and readiness for audits, inspections, and manufacturing activities. This role provides operational support for platforms such as SAP, Batch Reporting, OSI PI, Maximo, and TrackWise Digital, while collaborating across departments to maintain documentation, support investigations, and assist with introduction of new products including toxicology and clinical materials. The role ensures systems and documentation are aligned with current Good Manufacturing Practices (GMP) and evolving regulatory expectations.

Requirements

• Proven ability to manage multiple projects and meet deadlines in a dynamic, regulated environment.
• Strong cross-functional collaboration and communication skills.
• Working knowledge of US and EU GMP regulations.
• Sound understanding of pharmaceutical manufacturing operations and documentation.
• Excellent written and verbal communication skills.
• Strong attention to detail with a commitment to quality.
• Self-motivated, organized, and dependable with a results-oriented mindset.
• Bachelor's Degree in a scientific discipline or equivalent experience.
• Minimum of 3 to 5 years’ experience in pharmaceutical or medical device manufacturing, Quality Assurance, or related GMP-regulated roles.

Nice To Haves

• Experience using project management tools such as GANTT charts, PERT charts, and MS Project.
• Familiarity with SAP, Rockwell Automation, Signavio, Veeva, and TrackWise Digital.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Understanding of 21 CFR Part 11 compliance and electronic records management.

Responsibilities

• Partner with manufacturing personnel to proactively identify and resolve GMP non-compliance issues related to manufacturing systems and processes.
• Author and revise SOPs and GMP documentation in support of new or updated manufacturing processes in collaboration with cross-functional teams.
• Coordinate and expedite the review and approval of GMP documents to meet project and compliance timelines.
• Review executed GMP documentation for accuracy and completeness to support production and batch release.
• Facilitate or support investigations, deviations, and CAPAs, serving as SME or scribe where needed.
• Collaborate with departments such as IT, Automation, Quality, Validation, and Supply Chain to resolve system issues and ensure compliance.
• Support preparation of documents for regulatory submissions, validations, and new product introductions.
• Drive continuous improvement initiatives related to system efficiency, quality, and compliance, utilizing the TrackWise Digital system as applicable for Change Controls and Change Action tasks.
• Maintain up-to-date knowledge of regulatory requirements and internal procedures; ensure documents remain inspection-ready.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level