Thermo Fisher Scientific Job - 41539269 | CareerArc
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Company: Thermo Fisher Scientific
Location: Manatí, Puerto Rico
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Pharmaceutical Services Group

How will you make an impact?

Ensure the continuous operation of all Manufacturing, Packaging and Utilities automated systems. Support the Process Engineering team during process integration for major computer system applications that impact the Manufacturing, Packaging and Utilities Areas. Assure computer systems operations are maintained considering Plant policies, procedures and FDA regulations under cGMP's and other regulations applicable.

What will you do?

  • Perform process equipment analysis and recommends improvements to existing processes through the use of state-of-the-art computer technology and participates proactively as a team member of implementation projects for new integrated business application and processes automation, providing consulting advice in the use and management of technology.

  • Installs, configures, troubleshoots, and maintains computerized systems in Manufacturing, Packaging and Utilities Areas. These systems include (not limited to), PLCs, SCADA, and Fourth generation languages for interfaces and report development.

  • Leads proactive problem-solving efforts for manufacturing and packaging processes. Troubleshoots and resolves process equipment issues, diagnoses technical problems and determines short-term and long-term solutions.

  • Develops and implements methods to systematically evaluate manufacturing process and equipment problems, analyze process data from equipment failures, and make recommendations to prevent recurrences.

  • Designs/approves equipment layout.

  • Designs modifications to existing process equipment and implements changes for new processes.

  • Defines process requirements on capital projects including participating in selection of new manufacturing equipment.

  • Provides process engineering support to ensure operational success of the Maintenance coverage program for automated equipment.

  • Provides technical expertise and guidance for site process projects. Provides knowledge of manufacturing standards.

  • Develops, implements, and maintains safety and process systems and identifies, resolves, and recommends solutions to remove systemic limitations and barriers.

  • Promotes GMP compliance within the workplace by following site GMP procedures. Incorporate GMP and regulatory compliance into all assigned projects scope, design and construction work.

  • Maintains the necessary compliance status required by company and facility standards.

How will you get here?

Education

Bachelor's degree in Computer Science, Engineering or related discipline is required.

Experience

  • Five (5) years of progressive experience in pharmaceutical operations or Manufacturing processes and experience in the development, support of computerized automation systems, and networks is preferred

  • Plus two (2) years' experience of experience in Computerized Systems Validation.

  • Proven experience issuing and preparing Computerized Functional Requirements and Design Specifications.

Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities

  • Proven project management skills. Proficient knowledge of computer system life cycle concepts, change control systems and FDA regulatory requirements, including 21 CFR Part 11.

  • Familiar with a variety of control system concepts, practices and procedures.

  • Understands PLC ladder logic or function block and/or DCS system development.

  • Knowledge in Automation/Process Instrumentation/Controls/Program Logic.

  • In-depth knowledge of the science and physics involved in the design, installation, commissioning and validation/qualification of computerized systems and PLCs as applied to pharmaceutical production environment.

  • Prefer knowledge of A-B and Modicon PLCs and/or DCS D/3 and Delta V experience.

  • Broad knowledge of relevant governmental regulations, cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant.

  • Experience with external and internal regulatory audits

  • Development of configurable control and historian and database program development.

  • Outstanding attention to detail and organizational skills.

  • Demonstrates ability to maintain a high degree of confidentiality, discretion and independent judgment.

  • Demonstrated leadership experience and project management skills.

  • Self-starter, mature, independent and dependable.

  • Ability to work in fast paced results orientated environment.

  • Effective time management, multitasking and prioritization skills.

  • Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures

  • Excellent interpersonal skills to establish and maintain effective working relationships with internal and external customers, including tact to handle sensitive matters.

  • Highly effective verbal and written communication skills, Spanish & English.

  • Proficiency in Microsoft Suite (Word, Excel, PowerPoint)

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 90,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.


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