Overview: Directly responsible for the execution of all automation & validation assignments to fulfill our client’s needs. Support the design, implementation, troubleshooting, and validation of automation systems and manufacturing equipment in the pharmaceutical industry. This role applies engineering principles and validation protocols to ensure compliance with cGMP and regulatory requirements, while contributing to project execution, documentation, and system optimization. Responsibilities:

Apply automation knowledge for manufacturing equipment applied to the pharmaceutical industry.
Apply technical knowledge in automation and controls to support pharmaceutical manufacturing equipment.
Execute day-to-day activities involving software and hardware systems, including PLC and stand-alone control systems.
Develop, troubleshoot, and validate PLC and HMI/SCADA software.
Perform inspections and verifications of automated systems based on approved execution protocols and SOPs.
Generate and maintain documentation, including System Functional Design Specifications, protocols, and validation reports.
Support system commissioning and equipment qualifications in compliance with industry regulations and project requirements.
Conduct troubleshooting and root cause analysis for equipment and system malfunctions.
Collaborate with cross-functional teams to ensure alignment with customer policies, procedures, and quality standards.
Manage assigned deliverables to meet schedule, scope, and quality expectations.
Participate in team meetings and provide regular project status updates.
Assist in system administration tasks, including support for networked equipment and Microsoft-based systems.
Perform any additional tasks assigned by supervisor related to client or project needs.

QUALIFICATIONS:

Bachelor’s degree in Engineering (Electrical, Electronics, Computer, or related), Manufacturing Technology, or a closely related field.
Basic knowledge in automation, PLC, and Stand-Alone systems.
Basic knowledge of local access procedures, including but not limited to: Safety procedures, electronic systems access (email, phone, others).
Project management basic concepts: timeline follow-up, schedule reviews, predecessor.
People skills for interdisciplinary share.
Self-driven and schedule-oriented.
Strong skill in working independently and effectively interacting with various levels.
Basic knowledge with network and system administration of Microsoft-based systems, Visual Studio, ASP.Net, and SQL is preferred.
Demonstrated computer skills, including but not limited to, MS Excel, Word, PowerPoint, Visio, Project, and AutoCAD.
Proven ability to simultaneously manage multiple projects and initiatives.
Ability to work both independently and in partnership with others.
Bilingual: English and Spanish. Written and verbal.

PHYSICAL/MENTAL REQUIREMENTS

Able to stand for extended hours for test runs
May require extended working shifts.
Able to climb ladders/steps
Able to lift items of 25lbs
Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements.

We are an equal opportunity employer. We are committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, veteran status, disability, or any other protected status under applicable law.

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Validation Specialist