Solutions Architect

Job Title: Solutions Architect

Job Description

The IT Solutions Architect/Engineer is a hands-on technical leader responsible for the integration and implementation of multiple critical enterprise systems. This role involves designing and managing the architecture that connects the facility's ERP, Manufacturing Execution System (MES), EMS, Security System, Quality Management System (QMS), and other software platforms to ensure a seamless digital workflow. The position requires collaboration with software vendors and internal teams to deploy and validate these systems, ensuring they meet both operational needs and regulatory requirements, including FDA 21 CFR Part 11 for electronic records and signatures. The ideal candidate has experience in pharmaceutical or FDA-regulated environments and possesses the technical expertise to ensure data integrity, system compliance, and efficient integration of manufacturing and quality data across the organization.

Responsibilities

• Define and implement the overall IT architecture linking manufacturing and business systems.
• Design integration strategies between ERP, MES, QMS, and other applications to ensure secure and accurate data flow.
• Create and maintain architecture diagrams and data workflow plans to illustrate system interfaces.
• Lead planning and execution of system implementations and upgrades for enterprise software.
• Collaborate with system vendors and cross-functional departments to gather requirements and configure systems.
• Manage project timelines, resources, and testing phases to ensure successful deployment.
• Ensure all computerized systems are compliant with FDA regulations (21 CFR Part 11) and GxP guidelines.
• Oversee or coordinate Computer System Validation (CSV) efforts for new and updated systems.
• Develop and manage data integration workflows or middleware solutions to automate data exchange.
• Serve as the technical owner for the ERP, MES, HRIS, QMS, and related systems.
• Monitor system performance and resolve issues related to software bugs, network problems, or user errors.
• Maintain comprehensive documentation for the IT landscape and provide training to end-users and IT support staff.

Essential Skills

• 5 years of experience in IT systems architecture, integration, or engineering.
• Experience in pharmaceutical, biotech, or other FDA-regulated industries.
• Hands-on experience with ERP systems (e.g., SAP, Oracle, Microsoft Dynamics) and MES in a production environment.
• Knowledge of 21 CFR Part 11 requirements and general data integrity principles (ALCOA ).
• Experience with Computer System Validation (CSV) processes and GAMP 5 guidelines.
• Proficiency in database management and system integration techniques.
• Ability to develop or oversee custom integrations using APIs, web services, or middleware.
• Comfort with scripting or programming for data migration or automation (e.g., SQL, Python).

Additional Skills & Qualifications

• Bachelor’s degree (or higher) in Computer Science, Information Systems, Engineering, or a related field.
• Master’s degree or specialized training in information technology or systems engineering is a plus.
• Experience in leading cross-functional IT projects and vendor management.
• Familiarity with EMS and quality management systems (QMS).
• Knowledge of additional systems such as data historians, SCADA/PLC integrations, or electronic batch record systems is a plus.
• Track record of leading digital transformation projects.

Work Environment

This exciting opportunity is set in a startup environment that plans to rapidly expand into multiple locations. The position is based in an FDA-registered 503B outsourcing facility specializing in sterile compounded medications for critical care settings, operating under strict current Good Manufacturing Practices (cGMP) and regulatory oversight. The role follows a Monday to Friday schedule from 9am to 5pm in a clean room environment. This is a flexible job title with advancement opportunities, and the company is open to relocation candidates and can sponsor H1B/OPT visas.

Job Type & Location

This position based out of Colonie, New York.

Pay and Benefits

The pay range for this position is $50.00 - $75.00/hr.

Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Colonie,NY.

Application Deadline

This position is anticipated to close on Oct 31, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $50 - $75