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Senior Automation Engineer

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.

Your Responsibilities

 

The Senior Automation Engineer is responsible for planning, designing, analyzing and managing automation systems and projects for manufacturing processes and systems in a regulated pharmaceutical industrial plant. Performs engineering design evaluations. Recommends alterations to development and design to improve quality of products, and/or procedures. Maximizes efficiency by analyzing automation system composition, communication, logic, and workforce utilization.

 

Essential Functions

 

  • Determines hardware, software, and network architecture necessary to achieve manufacturing goals according to product specifications
  • Leads project teams and drive project milestones to design, develop, and improve process automation
  • Manage and direct automation / controls integrators across multiple internal and CAPEX projects. Maintain overall project schedules, issues log (and drives to resolution) and project budgets
  • Prepares presentations to executive leadership with updates on approved projects and justification and cost estimation on future projects
  • Provide technical leadership on design, commissioning, and start-up of control systems supporting manufacturing, testing, and storage of biotech and pharmaceutical processes, systems, and facilities. Undertake technical reviews for documents generated by others to ensure that technical and regulatory requirements are met
  • Work with full range of Biotech/pharma project phase execution including all design phases (conceptual design, basic design, detailed design), construction support and commissioning
  • May support CQV (Commissioning, qualification and validation), shut-down, and project hand-over activities
  • Generate, revise, and troubleshoot automation code and associated specifications and drawings as required
  • Support field wiring diagram verifications, loop testing, change owner responsibilities and workplan field test documents
  • Perform code review to ensure code meets its specifications and requirements and is fit for purpose
  • Assist process and validation teams in execution of process, cleaning, equipment, and utility C&Q efforts
  • Write, oversee and execute commissioning and/or qualification protocols and associated reports to verify systems are qualified for use
  • Oversees, manages, and partners with process and equipment engineers to provide guidance and leadership to colleagues in technical aspects, thoroughness and detail oriented in ensuring fulfillment of project deliverables of team
  • May be involved with other aspects such as supplier-management (maintain key Supplier relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of supplier resources for effective project delivery, supporting business development
  • Provide technical support to the operations as required for maintaining production
  • Responsible for Design, Installation, and qualification of Automation systems for batch processing tanks, solvent recovery system, filter dryers, HPLCs, filtration system, Lyophilizers, ultra-low freezers, HVAC, solvent distribution and recovery system, compressed air, purified water, and waste-water system
  • Collaborate with Production and Controls Team to develop and streamline production process in automating the new and existing system by harmonizing and leveraging technology developed by Center of Excellence (Bachem Headquarters)
  • Develop and train cross-functional team members on utilization and maintaining new Automation systems for equipment and system by creating roadmap, improving existing process, creating new procedures, job aids, SOPs and protocols as well as training of staff for these expectations
  • Troubleshoot Automation Systems, and monitor and trend to ensure that equipment works to its specifications and appropriate capacities
  • Ensures compliance of company policies, procedures and objectives regarding processes, initiatives, and projects

 

Your Profile

 

  • Bachelor’s Degree in Engineering
  • Minimum of 10 years’ qualified work experience with minimum 5 in automation engineering.
  • Working Knowledge of ISA and IEE Standards and Industry Code as it relates to Chemical, Pharmaceutical facilities or related facilities
  • Knowledge of NEC, UL, and FDA title 21 standards and requirements
  • Technical knowledge of automation, controls, instrumentation, batch programming, Programmable Logic Controllers, Distributed Control Systems, Supervisory Control and Data Acquisition systems, Building Automation Systems, IT and OT networks and technologies
  • Knowledge of batch processing and recipe management
  • Direct complete project life cycle from design, planning, and implementation to validation. Act as project manager across multiple projects
  • Experience with electrical and program troubleshooting
  • Ability to safely work with electrical circuits up to 480VAC
  • Excellent written and oral communication skills
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Detail oriented with the ability to troubleshoot and resolve problems.
  • Ability to work independently, manage one’s time, and function well in a team environment
  • Experience with Allen Bradley, Siemens, Omron, Delta-V, Schneider, and Opto automation platforms.
  • Experience with MSSQL and OSI PI databases
  • Experience with Copadata Zenon, Ignition, and PlantPAX SCADA platforms
  • Experience with contemporary process control systems such as DCS (Rockwell), BAS (Siemens, Schneider, Honeywell), PLC (Rockwell, GE, ABB), and SCADA (iFix, FT)
  • Experience with plant floor historian databases, interfaces, and reporting tools such as OSI, PiHistorian, and SQL Server.
  • Experience writing, reviewing, and updating design and functional specifications.
  • Experience writing and executing commissioning and verification protocols and associated reports
  • Familiar with integrated commissioning and validation as well as ASTM E2500 verification methods
  • Experience utilizing risk-based methodologies in testing
  • Experience with manufacturing processes and equipment such as CIP/COP systems, filtration skids, chromatography, fermentors/bioreactors, sterilization, and lyophilization equipment
  • Experience with hygienic utility systems such as purified water, WFI, clean steam, and process air
  • Experienced with Office software such as Word and Excel
  • Travel may be required on occasion

 

 

Salary Range: $104,728 - $144,000

 

Placement of new hires in the wage range is based on several factors including education, skill sets, experience, and training.

 

Total Rewards

 

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

 

Corporate Social Responsibility

 

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness.  EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem.

            

Bachem Americas is an Equal Opportunity Employer

 

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.


Nearest Major Market: San Diego