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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 Plant Engineer II provides engineering support throughout the various manufacturing facilities in areas such as process equipment improvements, technological advancements, capital projects, existing manufacturing equipment, cost improvements, facility maintenance, safety and environmental regulation. Demonstrate good engineering, effective collaboration, partnering and teamwork skills when interacting with internal and external resources. Support review, and approval of the conceptual, basic and detailed design, procurement, installation and start-up for new plants facilities, equipment, utilities and systems. Ensure inclusion of existing site facility and engineering team members in the learning process and design process for new plant systems. Systems include water pretreatment, generation of WFI, plant steam, Clean Steam, Clean Air, Clean Gases, Plant HVAC, Fill Finish equipment and lyophilization. Independently lead Critical and Plant Utility projects from inception to completion.JOB DUTIES
Support safety through personal engagement and promote individual accountability for safety within the plant Engineering Department. Ensure risks to employee health and safety are rigidly controlled.
Provide engineer support for Facilities, Systems, Utilities and Equipment (FSUE) execution of projects/assignments from initial concept to final closeout.
Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; Develops alternative solutions; works well in group problem solving situations. provides the technical support for the user with respect to investigations, re-occurring problems, required modifications, optimizations and Continuous Improvements.
Work with end users to develop system requirements, specification of equipment/buildings, support fabrication and perform Factory/Site Acceptance Testing.
Prepare URS, ETOPs, Risk Assessments, Safety Assessments and other good engineering documents associated with the Facilities, Systems, Utilities and Equipment (FSUE) as required.
Execute good Engineering practices for new equipment/Systems/utilities as applicable.
Work closely with other support groups such as MTS, Automation, Manufacturing, Quality Assurance, Facility Operations and Maintenance/Metrology, Engineering, EHS&S, and Quality Control to ensure that LSNE assets are well engineered and maintained throughout their lifecycles.
Assist with the factory acceptance testing (FAT), site acceptance testing (SAT), setup, and commissioning of Facilities, Systems, Utilities and Equipment (FSUE).
Procure new equipment, create and maintain the appropriate engineering records including equipment records and manuals, drawings and diagrams, inspection reports per Good Engineering policies.
Support the execution of start-up and commissioning activities on Equipment, utility and GMP manufacturing Facilities, Systems, Utilities and Equipment.
Troubleshooting Equipment/system failures, author deviations for unusual operations.
Demonstrate an in-depth technical knowledge of Facilities, Systems, Utilities and Equipment (FSUE) systems.
Initiate, lead and execute Facilities, Systems, Utilities and Equipment (FSUE), cost improvement projects. Demonstrated proficiency in the application of basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharmaceutical manufacturing processes.
PROFESSIONAL SKILLS
Strong organization, interpersonal, oral and good written communication skills.
Demonstrated proficiency in the application of basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharma/medical device processes.
Proficiency with standard software applications, including MS Word, MS Excel, MS Project, MS Power Point,
Knowledge of GMP and FDA regulatory requirements for drugs and/or medical devices.
EXPERIENCE
Experience with aseptic liquid filling of vials, CIP/SIP and Clean Room, lyophilization, aseptic filling of vials, and aseptic processes, including refrigerated and frozen capabilities a Plus.
Process control and Instrumentation for facility control systems experience is desired.
Experience with Computerized Maintenance systems (CMMS), AutoCAD, SolidWorks, PLC & SCADA control system.
Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus.
EDUCATION
BS in Chemical, Mechanical, or other Engineering degree from an accredited university.
A minimum of 3 plus years’ experience in engineering, facilities clean utilities and/or plant utilities, preferably in the biotechnology, medical device or pharmaceutical industry.
QUALITIES
Effectively support internal and external relationships, key stakeholders and vendors.
Strong understanding of team and group dynamics. Contributes to creating a positive and collaborative culture.
Hands on and agile to working in a fast paced CMO environment.
Strong Technical writing skills
PHYSICAL REQUIREMENTS & MENTAL DEMANDS
Must be able to gown appropriately and lift and/or move up to 50 pounds
Must be able to successfully prioritize and manage work projects and assignments.
COMMUNICATIONS & CONTACTS
Interacts with all departmental staff.
Works closely with Engineering, Manufacturing, MTS, Quality, EH&S, Facilities, and Validation
TRAVEL < 10% or >15%#LI-LL1Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/) 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. Why work for PCI Pharma Services?At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Vacancy caducado!