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Considered the founder of the industry, our client has been delivering on the promise of biotechnology for over 40 years. Our client is considered the leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. We are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.
Perform automation and instrumentation and control engineering design services for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement.
Produce and review design drawings and specification documents (URS, FS, DS, etc.).
Generate, execute, and review design testing, generate and participate in functional specification testing, and perform field inspection services.
Generate, execute, and review Installation, Operational, and Performance Qualification protocols.
Generate, review, and approve GMP Lifecycle Documents (e.g. risk documents, trace matrices, periodic review, etc.)
Initiate, execute, and track progress of change records.
Manage personal project activities (design and qualification) following business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget.
Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met.
Lead the start-up and troubleshooting of automation and critical process utility systems.
Lead plant operations to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings.
Adhere to site SOPs and WIs for daily and project deliverables and provide improvements to business processes.
Lead inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans).
Attendance and participation in department and staff meetings.
Maintain training qualifications.
Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines.
Automation lead for equipment/software FAT, field testing and commissioning.
Interact with vendors to ensure systems meet site requirements.
Provide scope, qualification, resource, and budget estimates for automation impacting projects.
Manage contractor staff, track project deliverables, and provide status updates to project team.
Provide input into Master Plans and Project Plans with automation scope.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Fosters a positive safety culture in which no one gets hurt.
Lead work of the Engineering Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting.
Experience with Biopharmaceutical manufacturing, design or/and construction.
Knowledge of process, utility and building control systems.
Knowledge of GMP guidelines, experience in generation of controlled documents.
Qualification experience related to control and computer systems.
Ability to generate engineering drawings and specifications.
Knowledge of ISA standards and practices for instrumentation.
Knowledge of PID control theories and techniques.
Knowledge of programmable logic controllers, and associated programming languages (RS Logix Preferred).
Practical knowledge of distributed control systems, and associated programming languages – (DeltaV and Seimens Insight Apogee Preferred).
Knowledge of computer aided manufacturing automation.
Demonstrate good organizational and time utilization skills.
Demonstrate good written and verbal communication skills.
Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility.
Demonstrate strong working knowledge of PC based programs and web based systems.
Ability to work most of the time independently with minimal direct supervision.
Demonstrate good interpersonal skills with an ability to interact well with a variety of personalities, discipline skills and educational levels.
Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 5 years experience, or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 4 years experience.
Minimum of 8 years applicable automation and/or instrument and control system experience.
Minimum of 5 years in the pharmaceutical/biotech industry/GMP experience.
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