Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
JOB SUMMARY
The Senior Automation Engineer works under the direction of the Senior Automation Manager while also utilizing independent judgment to perform the day-to-day project duties of designing, developing, and implementing control systems. The Senior Automation Engineer will play a key role of work ownership and accountability for PCI automation systems. The Senior Automation Engineer ensures new systems meet stakeholder requirements, changes to existing systems are performed in a controlled manner and systems are in an inspection ready state. The Sr. Automation Engineer possesses expertise in engineering, design, installation, and start-up of automation systems. They will assist manufacturing operations with problem solving regarding automation systems.
Essential Duties and Responsibilities:
- Develop and edit engineering design documents, technical evaluations, and test plans for cGMP process equipment, utilities and follow GAMP 5 and PCI Data integrity guidelines.
- Provide process automation (SCADA, PLC's, HMI's) programing and building management support.
- Perform troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software.
- Maintain the Historical database, Factory Talk PI Historian, and local historical solutions.
- Support and maintain reporting services and report creation.
- Take leadership during the entire life cycle of automation projects, from concept to feasibility and from fabrication and test to production.
- Generate standard operating procedures to administer and manage control systems. Including the areas of backups/restores, configuration management, user access and incident handling.
- Work hand in hand with Facilities, Engineering, and Operations teams to support projects and operational needs.
- Implement, maintain, and optimize automated platforms for the commercial and research laboratories.
- Prepare RFQ’s and solicit quotations from automation suppliers.
- Evaluate supplier quotations to determine the best combination of technical solution, cost and timing.
- Develop budget, schedule for projects, and manage projects to stay within them.
- Conduct equipment design reviews and provide design guidance to suppliers and status reports.
- Provide on-site support during machine build, debug and testing/qualification.
- Supervise installation and testing to verify requirements and specifications are met.
- Develop and execute data backup procedures and disaster recovery strategies of automation systems, always ensuring data integrity and security.
- Write cGxP documentation such as SOPs, change controls, incidents, and deviations, planned deviations, and installation qualifications. Ensures documentation complies with cGxPs and other applicable regulations relating to GXP automated and control systems.
- Responsible for timely completion of work orders, deviations and change controls related to control systems.
- Responsible for generating test scripts related to control system changes.
- Support investigations to identify root causes and required changes to fix.
- Responsible for generating and maintaining control system documentation: functional specifications, I/O Lists, wiring diagrams etc.
- Collaborate and support external departments.
- Responsible for identifying and implementing solutions that reduce deviations, processing time or increase system inspections readiness.
- Provide 24/7 on-call shift Support as required.
Qualifications
- Bachelor’s degree in engineering, Computer Science, or related field, preferred.
- Proven experience as an Automation Engineer, preferably in the pharmaceutical industry.
- A minimum of 8-10 years’ experience programming and or troubleshooting PLC’s and HMI/SCADA applications, preferable in a qualified environment.
- Experience with selection, installation and troubleshooting field instrumentation: pressure, temperature, proximity switches, scales, level transmitters.
- Experience with design, installation, startup of VFDs and Motor Starters.
- Experience with Microsoft SQL Server Databases including setup/configuration of new database, running queries, programming stored procedures, and configuration of security and backups and notifications.
- Experience with FactoryTalk Historian database or OSI PI: installation and setup, backup, security configuration, configuration of points and ability to monitor performance and troubleshoot networking issues.
- Experience designing and troubleshooting control panel electrical circuits <=480V in accordance with NEC.
- Application of cGxPs and 21CFR part 11 to control system implementation.
- Experience integrating/interfacing equipment and required signal exchange.
- Proficiency in Microsoft Office including Word, Excel, PowerPoint, and Visio.
- Excellent organizational skills
- Excellent communication skills both oral and written.
- Able to read/interpret engineering drawings and design documents. Ability to read and interpret engineering drawings, P&IDs and electrical schematics.
- Take leadership during the entire life cycle of automation projects, from concept to feasibility and from fabrication and test to production. Work both independently and in a team environment at all levels of the organization.
- This position requires a high level of attention to detail along with the ability to develop a strong understanding of Equipment design standards.
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
