Automation Lead position for Sterile area Equipment Maintenance Engineering.

Control & Automation Lead, job description: We are looking for an experienced Automation Engineer to join our team! As an Automation Lead, you will be responsible for maintenance and automation of sterile processes equipment

Control & Automation Lead, Duties and responsibilities:

- Exploring and implementing new ways to automate systems.

- Designing and testing automation equipment and processes.

- Programming new automated components.

- Identifying automation related quality events and writing reports.

- Eliminating defects and errors with hardware and software.

- Collaborating with vendors for online breakdown management.

Key Technical Competencies Required

- Managing and maintaining Control systems equipment, and energy management systems

- Optimization of automation and controls systems designs & Creation of automation standards for existing and new sites.

- Technical support to internal customer issues, resolve automation system related issues to mitigate the associated operational risks in the areas of continuous production activities, GMP Compliance, Business and EHS.

- Lead and support technical root cause analysis, incident investigations and troubleshooting issues related to instrumentation and equipment control systems.

- Collaborating with cross-functional teams to identify opportunities for improvement and optimization of automation systems

- Support the operation/ownership Data Monitoring & Control System.

- Automation experience (Installation and configuration of human machine interfaces (HMI) and SCADA systems)

- Support set-up of automation function for (SCADA, IT Protocols, configuration of servers, CMMS, BMS & EMS).

- Work with the Project Team to execute a timely start-up to the Automation project.

- Ensure high levels of uptime for all required systems to support Manufacturing plans

- Ensure compliance with regulatory policies including Quality, IT Security and EHS.

- Lead upgrade projects, as appropriate, to avoid problems caused by obsolescence.

- Act as a Subject Matter Expert for Automation

- Ownership and administration of process automation systems in a GMP regulated manufacturing(OSD & Injectable and Utilities areas).

- Lead and support system improvements, development of detailed specification, engineering documents, and standard operating procedures.

- Solve complex problems, deliver lifecycle management and operational excellence.

- Develop and manage change control requests per established SOPs and processes.

- Critically analyzing designs of existing systems, developing and recommending continuous improvements in line with the latest technology and regulatory standards.

- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.

- Excellent understanding of Automation & Control principles.

- Excellent Technical, analytical and organizational skills

- Independent, self-motivated, organized and able to multi-task in project environments.

- Clear and concise technical writing, and communication/presentation skills

- Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

- Proficient in managing relationships with stakeholders, coordinating and collaborating with teams from different departments in order to achieve common goals.

- Travel at various times may be required to support execution of projects

- Proficient in the problem solving, technical support, maintenance, specification adherence and validation of Process Control system.

System Owner - Project Support:

- Provide technical hardware, software and coding expertise to ensure new and upgraded systems are provided and maintained to meet business compliance and performance requirements.

- Manage miscellaneous 'small / medium projects', which will include; responsibility for management & co-ordination of project definition, engineering design, purchasing, installation, commissioning & qualification of equipment.

- Support new technology introductions by performing engineering assessments, implementing automation system configuration changes, and supporting engineering and qualification runs.

- Contribute to the development, implementation and maintenance of a Good Engineering Practice platform for effective delivery of projects.

Computerized System Life Cycle:

- Generate disaster recovery plans / procedure for site Computerized Systems (Configuration management, system backup).

- To support Computer Systems Validation for site Computerized Systems (Commissioning, Qualification, Operation).

- Support the review of Automation & Control maintenance plans.

- Support the continuous improvement of the Computerized System Life Cycle.

- Support the reduction of Automation & Control maintenance plans via data driven equipment performance and FMEA assessment.

- Create, maintain, and execute Automation & Control maintenance procedures for equipment / computerized systems, including use of appropriate personal protective equipment & safety procedures.

- Develop training methods / plans to be used to train members of the Engineering team and across functions: Maintenance / Operations.

- Provide computerized system configuration and user access management configuration management appropriate to each Computerized System.

Quality System:

- Document and investigate Automation & Control adverse events in accordance with site Unplanned Event procedures.

- Complete Quality system activities and records within respective due dates.

- Act as subject matter expert for review and implementation of Automation & Control tasks.

- Complete site training requirements.

- Adhere to all site policies and procedures to maintain the culture of quality compliance with Good Manufacturing Practices and Good Documentation Practices.

EHS Compliance:

- Ensure Compliance with site EHS systems and procedures e.g. Emergency response, Incident/Accident Investigation procedures etc.

- Ensure contractors are working within safety guidelines, using correct procedures and equipment.

- Ensure high standards of housekeeping are maintained in the area

- Ensure closure of EHS actions raised in a timely manner.

- Ensure attendance at EHS training modules as defined by the site training calendar.

- Bring to the attention of supervisor / manager / Safety Rep., EHS any suggestions that can improve safety on site.

- Ensure appropriate Personal protective clothing is worn at all times as detailed in SOPs.

- Ensure participation in relevant EHS unplanned events and ensure accidents/incidents are reported in a timely manner as assigned by the area Manager.

Control & Automation Assistant Lead , Requirements and qualifications:

- Minimum of a bachelor's degree in Instrumentation / CS&ML engineering or similar field.

- Proficiency in maintaining automation equipment.

- Experience with robotics, AI and machine learning

- Experience with project management

- Solid understanding of computer programming and software development

- Ability to troubleshoot equipment and perform complex system tests

- Strong leadership and problem-solving skills

- Excellent organizational skills and attention to detail

- Creative thinking skills

- Excellent verbal and written communication skills

- Strong analytical skills

- Ability to communicate well with other members of the team

- Excellent manual dexterity

- Ability to keep up with the latest technologies.

- A desire to continually upgrade technical knowledge.

- Experience with programming and troubleshooting PLC (e.g. Allen Bradley, Siemens), SCADA (e.g. IFix, InTouch, WinCC, Zenon, Ignition, Blue mountain, Infinity, Track wise and Veeva quality software) in pharmaceutical industry.

- Industrial Networking experience with ControlNet (CNET), Device Net, Profibus etc.

- Experienced in the use of Automation support tool such as RSLinx, RSNetworx, FactoryTalk Network Monitoring and architecture and SQL Data Historian.

- Knowledge of GAMP software development lifecycle standards: GAMP5, FDA 21 CFR Part 11 and EU Annex 11.

- Working knowledge of network architecture technologies including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration and Firewalls

- Solid leadership, technical writing, and communication/presentation skills

- Experience in change control, non-conformance, corrective and preventative actions, and validation practices

- Experience and involvement with successful Pre-Approval Inspection or equivalent regulatory audit involving Programmable Electronic Systems is desirable.