Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
‘Take your Career to a New Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which include the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in Top Pharmaceutical client sites in a diverse-cultural work setting.
We are looking for a Delta V Automation Engineer with solid DeltaV design and configuration skills. Responsible for Automation integration, modification and technical support, utilizing Good Manufacturing Procedure GMP lifecycle management within documentation, code, assessment of changes and improvements within the Process Control System (PCS). Position will be located in the San Diego Area for a duration of 6+ months with high possibility of extension.
- 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, 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.
- Support 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 standard operating procedures (SOPs) and work instructions (WIs) for daily and project deliverables and drive improvements to business processes.
- Support 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 ensure systems meet site requirements
- Provide scope, qualification, resource, and budget estimates for automation impacting projects.
- Generate, review, and maintain Master Plans and Project Plans with automation scope.
- Select external contractors with appropriate skill sets.
- Manage teams (contractor and FTE staff) by setting clear expectations for work delivered and behaviors. Monitor performance and ensure contractual obligations are met. Complete timely review of time sheets and invoices.
- Provide input into network/global business processes and procedures (e.g. GSPs).
- 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.
- Support work of the Engineering Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting.
- 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 4 years applicable automation and/or instrument and control system experience.Demonstrate good organization and time utilization skills
- Demonstrate strong written and verbal communication skills
- Ability to read and understand drawings and specifications
Knowledge, Skills and Abilities
- 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.
- Practical knowledge of ISA standards and practices for instrumentation.
- Practical knowledge of PID control theories and techniques.
- Practical knowledge of programmable logic controllers, and associated programming languages (RSLogix Preferred).
- Practical knowledge of distributed control systems, and associated programming languages (DeltaV and Siemens Insight Apogee Preferred).
- Practical knowledge of Manufacturing Execution System (Syncade Preferred).
- Knowledge of computer aided manufacturing automation.
- Demonstrate good organizational and time utilization skills.
- Demonstrate good interpersonal skills with an ability to interact well with a variety of personalities, discipline skills and educational levels.
- 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 independently with no direct supervision.
"PSC Biotech is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.”
Job Type: Full-time
- Dental insurance
- Health insurance
- Paid time off
- Delta V: 3 years (Preferred)
- Automation: 5 years (Required)
- Validation: 5 years (Preferred)
Visa Sponsorship Potentially Available:
- No: Not providing sponsorship for this job
- Waiting period may apply
- Only full-time employees eligible