Lead Automation Engineer for Greenfield site in Dundalk
This position requires technical expertise in automation and control systems supporting bioprocess equipment and plant utility systems. Experience automating batch and continuous upstream and downstream biopharmaceutical operations and associated utilities is essential. The candidate must have a comprehensive knowledge of GAMP 5, 21 CFR Part 11, Annex 11, ISA-S88.0 – Batch Control, ISA S95. Use of ASTM E2500 methodology is desirable. Must have extensive Delta V experience.
The candidate will drive functional commitments on the project and provide a high level of oversight and coordination to seamlessly integrate automation engineering efforts within the site. The candidate will consult with subject matter experts to ensure design solutions achieve long term business objectives and are supported by robust technical rationale to withstand scrutiny.
1. Bachelor’s degree in an Engineering discipline with ten plus (10+) years of experience in a Project Automation, Instrumentation and Controls role within the pharmaceutical or biotechnology industry. Minimum of 7 years of this should be in a Lead Role with extensive Project Management Experience.
2. At least 10 years of experience in a cGMP manufacturing environment or biologics process development
3. A proven track record of leading complex projects and cross-functional initiatives. With the ability to provide detailed Technical and Commercial Bid analysis to ensure that business needs are delivered.
4. Experience in implementing control system solutions across a wide range of DCS, QBMS, BMS, SCADA, HMI and PLC platforms is required. Particular experience with Delta V and Rockwell Automation Systems is of benefit.
5. Detailed knowledge of Instrumentation utilized within a complex facility to ensure a robust, maintainable facility.
6. In-depth understanding of large scale biotechnology unit operations, principles of biochemical engineering, and process data analysis.
7. Strives for results and sets ambitious tangible and measurable targets; takes personal responsibility for achieving results; reviews and evaluates progress against agreed targets, timelines and budgets
8. Proven ability to work with an EPC team, selected vendors, sub-contractors and in putting together a client Project Automation team to support the project where required
9. Strong knowledge and experience in GMP environment and working within Quality Systems
10. Must demonstrate experience of delivering solutions in line with all expected regulatory requirements and in accordance with corporate requirements. In addition, must ensure that all required plans, procedures, assessments etc are in place to ensure a smooth transition from Project to Operations phases.
11. Good knowledge and experience in EHS
12. Self-motivated with excellent communications skills
1. Proven leadership capabilities in a prior role;
2. Able to engage and align other stakeholders outside the project team;
3. Ability to understand and communicate risks and develop and execute contingency plans;
4. Extensive experience in the operation of large scale biotechnology processes;
5. Hands on experience with large scale biotechnology unit operations;
6. Bio-process manufacturing experience is highly desirable;
7. Proven ability to lead cross-functional and technical teams and align, motivate and empower team members
8. Knowledge of IT Network’s and Infrastructure required to deliver the chosen solutions