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Principal Technical Analyst - Manufacturing Systems
Posted 5 hours 18 minutes ago by Initial Therapeutics, Inc.
The Principal Technical Analyst - Manufacturing Systems will serve as a technical expert responsible for implementing and integrating manufacturing technologies across our biopharmaceutical facilities. You will execute hands on technical builds and integrations spanning Nymi biometric systems, IBM Maximo EAMS (Enterprise Asset Management System), and related manufacturing technologies, ensuring compliant deployment that supports operational excellence and predictive maintenance capabilities.
Responsibilities- Execute technical builds and integrations for manufacturing systems including Nymi biometric authentication, IBM Maximo EAMS, MES platforms, and associated technologies across designated facilities or project portfolios.
- Implement integration solutions connecting Maximo with predictive maintenance systems, MES workflows, and biometric access controls, following established architectural frameworks.
- Configure IBM Maximo EAMS modules including work management, asset management, and predictive maintenance capabilities for future release implementations.
- Build and test Nymi biometric integration points with manufacturing systems to enable secure, compliant user authentication workflows.
- Execute validation protocols (SDLC Framework aligned to CSA) for manufacturing technology implementations in FDA regulated environments, ensuring documentation meets regulatory standards.
- Implement change control procedures for system modifications, maintaining compliance throughout the development lifecycle.
- Configure master data elements within assigned systems following established data architecture standards.
- Support transformation of paper based processes into digital workflows while maintaining regulatory compliance requirements.
- Diagnose integration problems between Maximo, biometric systems, MES platforms, and automation equipment (Ignition, DeltaV, Rockwell).
- Partner with senior technical leads, automation engineers, and site stakeholders to understand requirements and deliver technical solutions aligned with business objectives.
- Practical experience dealing with project management, particularly dealing with the implementation of new technology and ways of doing things.
- Ability to understand and engage broader business strategy, work with key department leaders and stakeholders and align activities and initiatives.
- A demonstrated ability in creation of requirements, design documents and test scripts.
- Must be competent to work at the technical level of all phases of system design and implementation.
- Ability to communicate at all levels with clarity and precision both written and verbally together with strong presentation skills.
- Ability to anticipate client needs and propose alternative business solutions.
- Knowledge of GMP, 21 CFR Part 11 and Annex 11.
- BS/BA degree in Information Technology or related field.
- Principal: 8+ years of progressive industry/relevant experience.
- Staff: 10+ years of progressive industry/relevant experience.
- Level is determined based on qualifications relevant to the role.
This role may require on site work at our biopharmaceutical facilities. Flexibility for site location is essential.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Benefits include health and wellness programs (medical, dental, vision, life and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off and paid leaves (including military and parental leave) for eligible employees at all levels.
Initial Therapeutics, Inc.
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