Thermo Fisher Scientific Manager, Automation Engineering in Carlsbad, California
Job Title: Manager, Automation Engineering
Location/Division Specific Information
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
At Microbial Manufacturing Services (MMS), a new Business Unit within Thermo Fisher Scientific's Pharma Services Group, we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice.
How will you make an impact?
The Manager of Automation Engineering leads a professional support staff and contractors responsible for instrumentation and controls of manufacturing equipment, integration of equipment into enterprise applications (data historian, batch automation, and manufacturing execution system), and site continuous improvement efforts to achieve Pharma 4.0 goals. This includes the design, implementation, and documentation of automation projects and their lifecycle management in compliance with FDA and EU regulations. Represents the department regarding automation issues during regulatory meetings and audits. Identifies and resolves automation issues on a timely basis to avoid regulatory action and make recommendations to senior management. Performs a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, and motivating their team and peers to perform at their best.
What will you do?
Oversees, manages, and ensures the successful day-to-day operations of the Automation department for the site.
Manage a team accountable for all aspects of automation engineering activities to maintain performance as required by schedule and/or project timelines.
Generate, review, approve and control departmental documentation (e.g., SOPs and system reports). Participate in document revisions, providing input, as necessary.
Support the generation and execution of Validation life cycle documentation such as Systems Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Design Qualification (DQ) Validation Summary Reports, and Deviations reports for Manufacturing and process Equipment & Utilities as per Thermo Fisher guidelines.
Provide leadership and expertise for the automation engineering activities during the tech transfer of new products in the manufacturing facility.
Analyze and interpret system data to support investigations.
Establish and maintain cross-site relationship with other Thermo Fisher sites to promote and maintain best practices.
Co-ordinate and execute continuous improvement for key site projects to implement new equipment, technology, processes, or materials as required by the needs of the business aligned to the site objectives.
As part of the role you will represent the company at regulatory inspections (internal, external including FDA & MHRA), respond to questions, co-ordinate responses and corrective actions as appropriate.
Lead the site implementation of MES with IT partners and contractors
Lead the site implementation of data historian with IT partners and contractors
Ensure the Automation group provides life cycle support and administration of the data historian and MES applications
How will you get here?
Bachelor's Degree in Engineering, Science or related technical discipline
At least 8 years or more of experience in Automation Engineering in a cGMP environment. A seasoned leader with several years as a manager of people. Demonstrated project management and organizational skills. Experience configuring and administering systems. Demonstrated experience upgrading technology.
Knowledge, Skills, Abilities
Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision-making and ambition.
Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
Leadership Skills: Proven ability to influence others and lead significant change.
Strong communication skills both written and verbal, including technical writing
Ability to work on multiple projects simultaneously.
Proficient in Allen Bradley PLC or Emerson DeltaV controls
Proficient in a data historian and manufacturing execution system applications
Familiarity with OSIsoft PI, Rockwell PharmaSuite, SAP
Familiarity with GAMP and ISA 95 standards of OT
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.