ZL01-031025 Senior Process Automation Specialist

Veg Group; Barcelona; Presencial; EUR 50.000 - 90.000; Jornada completa

Descripción de la vacante

Join an established industry player as a Senior Process Automation Specialist, where you will leverage your expertise in automation and project management to enhance operational efficiency in the pharmaceutical sector. This role offers the opportunity to work with cutting-edge technologies, ensuring compliance with stringent regulatory standards while driving process improvements. You will be part of a dynamic team committed to excellence, engaging in diverse projects that challenge your skills and expand your knowledge. If you are passionate about innovation and dedicated to quality, this is the perfect opportunity to make a significant impact in a rewarding environment.

Formación

• 5+ years of experience in pharmaceutical operations with a focus on automation.
• Proficient in FDA regulatory requirements and project management.
• Bilingual in English and Spanish with strong communication skills.

Responsabilidades

• Manage installation and maintenance of computerized systems for operational continuity.
• Provide technical support and training during system upgrades and installations.
• Ensure compliance with GMP standards and manage automation projects.

Conocimientos

Project Management

Process Automation

Data Analysis

Technical Support

Communication Skills

Troubleshooting

Educación

Bachelor's in Electrical Engineering

Bachelor's in Computer Engineering

Bachelor's in Mechanical Engineering

Herramientas

Rockwell Automation Tools

PLC Systems

HMI

SCADA

Delta V

MS SQL Databases

Descripción del empleo

Career Opportunities with Validation & Engineering Group

A great place to work.

Current job opportunities are posted here as they become available.

ZL01-031025 Senior Process Automation Specialist

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in areas such as Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to the highest ethical standards for the following position:

• Engineering - Senior Process Automation Specialist

MINIMUM REQUIREMENTS:

• BS in electrical, computer, mechanical engineering, or related fields.
• Five (5) years of experience in pharmaceutical operations or manufacturing processes, with proven project management skills. At least four (4) of these five years should be in process automation within a pharmaceutical environment, including two (2) years in computerized systems validation.
• Proficient knowledge of computer system lifecycle concepts, change control systems, and FDA regulatory requirements, including 21 CFR Part 11.
• Experience in issuing and preparing Computerized Functional Requirements and Design Specifications.
• In-depth knowledge of the science and physics involved in the design, installation, commissioning, and validation/qualification of computerized systems and PLCs in a pharmaceutical production environment.
• Broad knowledge of relevant governmental regulations, cGMPs, and guidelines related to biopharmaceutical manufacturing.
• Experience with regulatory audits (FDA, EMA, etc.).
• Knowledge of pharmaceutical business processes and equipment.
• Understanding mechanical concepts, electrical controls theory, and electronic circuitry.
• Proven skills in project management, systems development, and implementation of manufacturing, MES, and quality systems.
• Ability to operate software packages used for data acquisition and PLC programming, including Rockwell Automation tools.
• Knowledge of data historians (e.g., OSI PI), MS SQL databases, and networking infrastructure.
• Ability to interpret electrical/mechanical drawings and review SOPs and work instructions.
• Flexible, responsible, and a self-starter with good organizational skills.
• Strong data analysis skills to detect inconsistencies and solve complex technical issues.
• Bilingual in English and Spanish, both written and verbal.
• Effective communication skills to interact with internal and external stakeholders at all levels.
• Ability to plan and prioritize multiple activities using sound project management skills.
• Willingness to work irregular hours, including shifts, weekends, and holidays.

DUTIES & RESPONSIBILITIES:

Supports automation and computerized systems by troubleshooting, leading activities, and implementing improvements to ensure operational continuity and reliability. Performs process analysis, recommends, and implements process improvements using advanced technology. Manages installation, troubleshooting, maintenance, qualification, and upgrades of computerized systems. Manages projects for new automation systems, ensuring compliance with security, environmental, health, safety, and GMP standards.

Key responsibilities include:

1. Ensuring continuous operation of process equipment, including programming and maintenance.
2. Providing technical support during installation, configuration, troubleshooting, maintenance, and upgrades of systems like PLCs, HMI, Delta V, SCADA, DCS/BAS, networking, and MES.
3. Developing analysis, recommending improvements, and performing software/hardware changes.
4. Participating in implementation projects, providing consulting on technology management.
5. Installing, configuring, troubleshooting, and maintaining computerized systems in manufacturing and utilities.
6. Providing user training and ongoing support.
7. Reviewing and testing programs for hardware/software compliance.
8. Evaluating change control requirements and documentation.
9. Supporting quality events, audits, CAPA, and related processes.
10. Providing project status updates and problem-solving initiatives.
11. Supporting standards for automation and system integration strategies.
12. Developing and reviewing operational, maintenance, security, backup, and disaster recovery procedures.
13. Engaging with vendors for problem resolution and implementing recommendations.
14. Completing CAPAs and other quality system actions.
15. Managing capital projects and automation initiatives timelines.
16. Supporting data integrity and cybersecurity programs.
17. Assisting in computer system validation programs.
18. Staying current with technological advancements.