This is a contract through the end of 2020, and would convert to permanent in Q1 of 2021 for the right fit!
Job Title: Automation Engineer
A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications. Our Automation Engineer’s primary responsibility is to provide automation support to the Carlsbad Viral and Gene Therapies Manufacturing Operations as part of the Process Automation group, focused on the PCS (Process Control System) to implement continuous improvement changes, support MAR (Make Assess Release) activities, and lead and / or assist with expense / capital projects.
While performing the duties, the employee is:
- Constantly required to sit and reach to use computers and other office/lab equipment
- Constantly required to view objects at close and distant ranges
- Frequently required to communicate with others
Employee frequently will work in an office environment and production area with computer equipment, machinery, tools, and moderate amounts of noise and activity. Employee may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment. Employee will conduct off- shift, weekend, and overtime duties as assigned by the manager of the employee.
Who you are:
- BS or MS Degree in Chemical, Electrical Engineering, Mechatronic Engineering, Mechanical Engineering, or Computer Science or equivalent training and experience.
- Minimum of 5 years in the design, implementation and/or support of instrumentation and control systems, preferably in the Bio-Pharmaceutical, Pharmaceutical, food or other batch processing industries.
- Working experience with Distributed Control Systems (DCS), Manufacturing Execution Systems (MES), software development methodologies and automated systems life cycle support in a regulated industry.
- Systematic knowledge of Automation Society (ISA) Standards S88 and S95 as well as the International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP) Guide to the Validation of Automated Systems.
- Thorough understanding of cGMPs (current Good Manufacturing Practices), particularly as they relate to the operation, validation and maintenance of computer-controlled systems.
- Comprehensive understanding of engineering techniques and principles and the ability to apply that knowledge as required.
- Thorough knowledge of Process & Instrumentation Diagrams (P&IDs), I&E (Instrumentation and Electrical), such as networking, architecture (including panels), IO / device configuration, and wiring diagrams.
- Work with Manufacturing, Quality, F&E (Facilities and Engineering), Process Engineering and Science and Technology departments to implement corrective actions and continuous improvement changes, and lead/support expense /capital projects. Develop, review, and approve applicable automation-related specifications and any other related documentation. Perform off-line and on-line configuration, testing, and peer reviewing, and procedures related to software configuration management in multiple environments. Support design, development and execution of Automation Change Records and qualification/commissioning test documentation.
- Perform troubleshooting of process, equipment, and system malfunctions or failures involving the PCS
- Perform quality discrepancy evaluations/assessments and provide support for investigations.
- Assist with equipment testing and debug activities.
- Review and assess change records, risk assessments, and user requirements.
- Represent automation engineering on multidisciplinary and cross-functional project teams.
- Perform cGMP reviews of executed Automation Work Plans and tests for completeness and accuracy.
- Knowledge of Rockwell, Emerson Syncade & DeltaV architecture, software programming, and communication protocols is preferred. Knowledge of scripting as it relates to automation-based DCS databases / software applications is a plus.
- Certifications such as CAP, P.E., PMP preferred but not required. Project management experience is a plus.
- Mentor incoming automation engineers, consultants, interns or rotational personnel
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
Job Types: Full-time, Contract
Pay: $60.00 - $80.00 per hour
- Distributed Control Systems: 5 years (Preferred)
- Manufacturing Execution Systems (MES): 1 year (Preferred)
- Automation Society Standards S88 and S95: 3 years (Preferred)
- implementation and/or support of instrumentation and control: 5 years (Required)
- GAMP: 3 years (Preferred)
- Project Management: 3 years (Preferred)
- International Society for Pharmaceutical Engineering (ISPE): 3 years (Preferred)