Process Control System SME

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Description:
As a Process Control System SME at Thermo Fisher Scientific, you will optimize production processes, implement new technologies, and drive continuous improvement initiatives. You'll work with cross-functional teams to ensure the efficient manufacture of high-quality products while maintaining compliance with regulatory requirements. This position offers the opportunity to contribute meaningfully by enabling our customers to make the world healthier, cleaner and safer through innovative manufacturing solutions.

Responsibilities:

• Collaboration with various departments (ex. QA, QC, Supply Chain, Manufacturing, I&T or rest of Automation) in project and operation phase in order to assure overall coordination of the dependencies and required exchange information for the execution of PCS.
• Act as an expert and drive the architecture setup, development, and standardization of the Process Control System (PCS)
• Contribute to computerized system related documentation for qualification and validation activities such as URS, FS, DS, FRA, etc. related to PCS.
• Lead and contribute to the development of different Standard Operating Procedures (SOPs), Work Instruction (WI) or Guidelines for qualification/validation and routine activities for PCS
• Support in the Package Units Integration into Siemens PCS7
• Provide technical support with a view to resolve problems related to PCS as rapidly as possible
• Part of automation piquet team as per Thermo Fisher Scientific piquet organization
• In the project phase, be responsible and accountable for the implementation of PCS solutions, including: System design, Hardware and software setup, Commissioning and start-up, Validation of both software and hardware components
• Ensure the PCS is implemented in line with site standards and regulatory requirements
• In the operational phase, maintain and support the functionality and availability of the PCS
• Ensure business continuity through reliable system operation, issue resolution, and controlled changes Ensures implementation of and alignment to current GMP rules, Quality policies, procedures and instructions for their area of responsibility.
• Ensures contribution of their organizational unit to continuous quality improvement initiatives and deviation reporting and follow-up.
• Maintains commitment to Thermo Fisher Scientific values and alignment to ethics and legal compliance standards.
• Takes personal accountability for their presence, performance, and productivity for the achievement of defined objectives.
• Thinks and acts with a customer-centric mentality.
• Is intellectually curious and embraces Practical Process Improvement (PPI)

Requirements:

• Degree (bachelor, masters or long experience in an equivalent position) in automation-, electro- or electronic- engineer, Dipl. Ing. or M.Sc. or B.Sc. or equivalent
• Minimum 5 years of successful project execution and major projects for computerized systems with high complexity and interfaces to other applications (SCADA, Process Control System, Clean Utilities Automation, Facility Monitoring System, Building Management System, Manufacturing Execution System), biotech/pharmaceutical or other industries.
• Proven experience with Siemens PCS7.
• Confirmed experience and knowledge in Automation, Hardware design, Software Design, PLC technology.
• In-depth working experience in regulated industries; knowledge of cGMP, 21 CFR part11 and validation is a plus.
• Proven project execution skills including document development and software implementation.
• Knowledge of active directory, DNS, IP networks and virtualization is a plus.
• Proven knowledge and understanding of ISA 95 and ISA 88 standards.
• Confirmed experience in cGxP qualification.
• Experience in support of multi-site projects is a plus.
• Fluent in written and spoken English; German proficiency is an advantage.