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Florence, South Carolina, USA, United States of America
Onsite
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job 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.
You'll be based in our Florence, South Carolina location, where you'll have the opportunity to work in a dynamic environment that fosters innovation and collaboration. You will support our Drug Substance Division at Thermo Fisher Scientific and play an important role in our company's success.
Under the direction of manager or senior engineer, assist the Engineering and Manufacturing groups to achieve site and departmental objectives. Provide technical support to support new equipment installations. Perform process simulations and assist in equipment design and optimization. Participate in cross-disciplinary project teams as necessary.
Administer, document and maintain the Patheon Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of Patheon Quality Systems tools, as well as direct actions.
Assist in technical aspects of the process including approving/reviewing lifecycle documents including P&IDs, criticality assessments, Quality Risk Assessments, Qualification/Validation documentation, and EH&S Process Hazards Analysis. Ensures documents are accurate and current.
Provide technical expertise in end to end processes including facility design, materials, cleaning, planning, maintaining, producing, and shipping.
Assist in Process and Technology Transfers.
Maintain state-of-the-art expertise in pharmaceutical and chemical processing technology.
Ensure regulatory compliance and drive continuous improvement in EH&S/Quality/Efficiency to improve right first time in all areas.
Conduct technical training.
Perform other duties as required.
This position generally does not include supervisory responsibilities but may mentor other engineering personnel, including co-ops and interns.
Bachelor of Science in Engineering (Chemical) required.
An advanced degree is preferred.
3-5 years of related experience required.
Knowledge of regulatory requirements which includes FDA, EPA/DHEC and OSHA.
Basic knowledge of statistical process control including Lean concepts, process and equipment modeling tools (such as ChemCAD or Aspen), business systems such as SAP, and Microsoft Office tools (including MS Project).
Ability to prepare and interpret P&IDs, engineering drawings, engineering specifications, vendor manuals, etc.
Excellent oral, written and presentation/communication skills; ability to interact effectively with all levels of employees; ability to multi-task and work under tight deadlines.
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk, hear or smell. The employee is occasionally required to walk and stoop, or kneel, crouch. The employee must also occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made for persons with disabilities -employee evaluation to determine fitness will be made by company physician(s). While performing the duties of this job, the employee is:
Occasionally exposed to various types of chemical substances. Carcinogens, Corrosives, Irritants, Toxins, Teratogens, Mutagens, lethals (MSDS information for review on an on-going basis).
Employee must comply with all applicable safety and security procedures:
Determine appropriate action beyond guidelines
Report potentially unsafe conditions
Conduct compliance monitoring, investigations and training within area of responsibility
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.