Bedford, New Hampshire, United States · On-site
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…
Skills: PLC Programming, HMI Applications, Automation System Design, cGMP, GAMP 5
Rockford, Illinois, United States · On-site
$27/hr–$32/hr
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…
Skills: Preventive Maintenance, Troubleshooting, Equipment Repair, SMED, OEE Optimization
Philadelphia, Pennsylvania, United States · On-site
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…
Skills: Strategic Account Management, Executive Relationship Building, Financial Acumen, P&L Management, Cross-functional Leadership
Bedford, New Hampshire, United States · On-site
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…
Skills: Facilities Maintenance, cGMP Compliance, Preventative Maintenance, HVAC, Leadership
Bedford, New Hampshire, United States · On-site
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…
Skills: Mechanical Maintenance, Electrical Maintenance, HVAC, Plumbing, GMP Compliance
Philadelphia, Pennsylvania, United States · Remote OK
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…
Skills: Workday Integrations, Core HCM, Advanced Reporting, Workday Studio, EIBs
San Diego, California, United States · On-site
$21/hr–$24/hr
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…
Skills: cGMP, Sterile Filtration, Formulation, In-process Testing, Visual Inspection
Dundalk, Leinster, Ireland · On-site
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…
Skills: Warehouse Management, GMP Compliance, Inventory Management, Leadership, H&S Regulations
Bedford, New Hampshire, United States · On-site
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…
Skills: Environmental Monitoring, Aseptic Gowning, Bioburden Testing, Endotoxin Testing, TOC/Conductivity Testing
Bedford, New Hampshire, United States · On-site
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…
Skills: Aseptic Manufacturing, cGMP Operations, FDA Regulatory Compliance, Team Leadership, Performance Management
León, Castile and León, Spain · On-site
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…
Skills: Formulation Development, GMP, FDA Standards, DoE Methodology, Pre-formulation
Bedford, New Hampshire, United States · On-site
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…
Skills: Aseptic Techniques, GMP, ISO Standards, Aseptic Filling, Lyophilization
Bedford, New Hampshire, United States · On-site
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…
Skills: Quality Assurance, GMP Compliance, Batch Record Review, Supplier Quality Management, Document Control
Blanchardstown, Leinster, Ireland · On-site
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…
Skills: Good Manufacturing Practice, Quality Control, Visual Inspection, Batch Documentation, Sampling Tests
Rockford, Illinois, United States · On-site
$24/hr–$29/hr
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…
Skills: Equipment Troubleshooting, Preventive Maintenance, Packaging Line Adjustment, Hand Tools, Power Tools
Rockford, Illinois, United States · Hybrid
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…
Skills: Network Architecture, SD-WAN, BGP, OSPF, EIGRP
Philadelphia, Pennsylvania, United States · On-site
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…
Skills: HVAC Maintenance, Plumbing, Electrical Troubleshooting, Carpentry, Drywall Repair
Rockford, Illinois, United States · On-site
$27/hr–$32/hr
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…
Skills: Preventive Maintenance, Troubleshooting, Equipment Repair, cGMP, GCP
San Diego, California, United States · On-site
$29/hr–$31/hr
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…
Skills: Materials Management, cGMP Standards, Inventory Control, ERP/MRP Systems, SOP Creation
Stamullen, Leinster, Ireland · Hybrid
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…
Skills: Administration, JDE, Microsoft Office, Problem Solving, Troubleshooting
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The Senior Automation Engineer is responsible for designing, developing, and releasing automation deliverables for biopharmaceutical manufacturing equipment. This includes managing the full project life cycle from concept to production and providing day-to-day support for GMP and non-GMP systems.
Requires a Bachelor's degree in Computer Science or Engineering and over 10 years of experience in a regulated FDA environment. Expertise in PLC/HMI applications, FactoryTalk software, and compliance with 21CFR Part 11 and GAMP5 is essential.
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 releasing deliverables used in the fabrication of equipment for pilot and commercial scale biopharmaceutical manufacturing (Primarily piping assemblies for fluid & gas handling and motorized agitation systems). Primary responsibility involves generating design plans. The Senior Automation Engineer will play a key role of work ownership and accountability for LSNE automation systems. The incumbent will develop support models to assure robust operations, manage vendor and software support contracts, and work closely with the Quality and Validation teams to ensure these systems are ready for use. The incumbent is to be the expert in a variety of automation systems, have a love of learning, and not be afraid to get into the details and execute to solve problems. The Sr. Automation Engineer possess expertise in engineering, design, installation and start-up of automation systems. They will assist manufacturing operations with problem solving regarding automation systems. May also develop code and design system architectures to define user compatibility.
JOB DUTIES
Develop and edit engineering design documents, technical evaluations, and test plans for cGMP process equipment, utilities and follow GAMP 5 and LSNE Data integrity guidelines.
Participate in Control System initiatives such as Change/Project Implementation, Incident/Issue Investigation & resolution, CAPA & Safety related corrective actions and manufacturing support. Participate in Control System initiatives such as Change/Project Implementation, Incident/Issue Investigation & resolution, CAPA & Safety related corrective actions and manufacturing support.
Support the operation of all GMP and non-GMP systems and other auxiliary equipment
Support all GMP and non-GMP systems and other auxiliary equipment with Programmable Logic Controllers (PLC’s).
Take leadership during the entire life cycle of automation projects, from concept to feasibility and from fabrication and test to production. Design and document new test methods to measure equipment performance.
Manage critical automation projects through the entire project life cycle and ensure systems are maintained in a validated state after going live.
Work hand in hand with Facilities, Engineering, and Operations teams to support projects and operational needs.
Develop and manage design standards for our automation platforms.
Implement, maintain, and optimize automated platforms for the commercial and research laboratories.
Provide configuration, development, and break/fix day-to-day support of automation systems.
Lead automation system documentation, prepare technical and user documentation, and conduct system training.
Lead system maintenance and manage automation life cycle (review application patching, document test plans, and execute test scripts). Prepare RFQ’s and solicit quotations from automation suppliers.
Design the layout of equipment and workspace for maximum efficiency and safety.
Design and engineer moderate and complex automation equipment, tooling and applications.
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 manufacturing solutions with the best combination of manual, semi-automation and/or full automation.
Support new product development automation needs, facilitate assembly processes through the implementation of assembly cells and automated equipment at NPI stage and ensure meeting development timeline.
PROFESSIONAL SKILLS
Able to prioritize and drive to results with a high emphasis on quality and to integrate and apply feedback in a professional manner.
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.
EXPERIENCE
10+ years’ experience in a regulated environment (e.g., FDA).
Manufacturing engineering experience, working with automated manufacturing processes.
Experience coding/configuring in process controls (Control Studio, Batch, etc.).
Experience working with PLC and HMI applications (including RSlinx, RSlogix5, 500, 5000, & Factory Talk View).
Experience with FactoryTalk software and applications.
Experience integrating/interfacing equipment to control systems via OPC, Ethernet IP, etc.
Experience with OSISoft Pi Historian and MES. Control panel and automation hardware design experience.
Demonstrated knowledge of 21CFR Part 11, Annex 11, and GAMP5.
EDUCATION
A Bachelor of Science degree in Computer Science, Chemical, Electrical or Mechanical Engineering.
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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
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.
CDMO. Inspired by tomorrow. Let's talk future™.
We are PCI Pharma Services. CDMO. Today’s Drug Development & Manufacturing, Advanced Drug Delivery & Drug Device Combination Products, Clinical Trial Services, and Commercial Packaging Technology. Inspired by tomorrow. We provide world-class solutions through intelligence, ingenuity and innovation, together, delivering life-changing therapies. Across 38 global sites and supported by more than 8,000 dedicated employees, we bring together leading technology and continued investment to deliver seamless solutions from development to commercialization, supporting our clients to improve the lives of patients worldwide.
Offices: 3001 Red Lion Rd, Philadelphia, PA 19114, US · 23 Commerce Dr, Bedford, New Hampshire 03110, US · 4545 Assembly Dr, Rockford, Illinois 61109, US · 6166 Nancy Ridge Dr, San Diego, California 92121, US · 977 Century Dr, Burlington, Ontario L7L 5J8, CA
CDMO. Inspired by tomorrow. Let's talk future™.
We are PCI Pharma Services. CDMO. Today’s Drug Development & Manufacturing, Advanced Drug Delivery & Drug Device Combination Products, Clinical Trial Services, and Commercial Packaging Technology. Inspired by tomorrow. We provide world-class solutions through intelligence, ingenuity and innovation, together, delivering life-changing therapies. Across 38 global sites and supported by more than 8,000 dedicated employees, we bring together leading technology and continued investment to deliver seamless solutions from development to commercialization, supporting our clients to improve the lives of patients worldwide.
Offices: 3001 Red Lion Rd, Philadelphia, PA 19114, US · 23 Commerce Dr, Bedford, New Hampshire 03110, US · 4545 Assembly Dr, Rockford, Illinois 61109, US · 6166 Nancy Ridge Dr, San Diego, California 92121, US · 977 Century Dr, Burlington, Ontario L7L 5J8, CA
