Process Development Engineer I (Temporary 6 Months)

Essential Duties & Responsibilities

• Perform routine lab and/or pilot plant work such as defined study or process execution with instructions per laboratory notebook, batch record or protocol.
• Participates in study executions and related scientific discussions. Can coordinate simple cross functional work (e.g. sample submissions) and work within timelines established by senior level engineers.
• Maintain and review laboratory notebooks according to applicable (GxP or R&D) standards and in-house standard operating procedures (SOPs).
• Record detailed observations. Tabulate, analyze, and with appropriate supervision, interpret data from analytical tests or process instrumentation.
• With guidance from senior engineers, draft simple Standard Operating Procedures/Work Instructions from equipment manuals. Provide redlines of SOP/WIs and/or batch records from review and execution.
• Ensures compliance with FDA and other regulatory bodies, GxP regulations, in-house standard operating procedures, and EH&S policies, as applicable.
• Follow company SOPs for day-to-day lab work, data analysis, and documentation.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Perform other related duties as assigned.

Knowledge, Skills & Abilities

• Familiarity with FDA guidelines and cGMP Procedures.
• Understanding of GxP requirements and ALCOA+ documentation requirements necessary for manufacturing development batches in a GxP environment.
• Knowledge of pharmaceutical process development and scale-up
• Knowledge of chemistry, engineering principles, and pharmaceutical industry.
• Familiarity with Human Machine Interface (HMI), automated systems and other computer software (Word, Excel, Visio, for example).
• Good documentation practice and technical writing ability.
• Effective written and oral communication skills.
• Ability to analyze complex development problems, propose and implement creative solutions.
• Ability to work independently with minimal supervision as well as cooperatively on a team.
• Must be able to work in a fast-paced, changing work environment, possess good time management skills and exhibit personal responsibility.

Core Values

This position is expected to operate within the framework of Tolmar's Core Values:

• Center on People: We commit to support the wellbeing of our patients and treat our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together with an enterprisewide mindset that lifts the whole organization.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risktaking that drives better ways of working.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• Bachelor's degree in Chemical Engineering, Mechanical Engineering or related field.
• One or more years' experience in an engineering environment within the Pharmaceutical/Biotech industry.

Working Conditions

• Working conditions are in an office, laboratory and manufacturing environment.
• Work may require occasional weekend and/or evening work.
• Work may require use of personal protective equipment such as Powered Air Purifying Respirator (PAPR).
• Work may require lifting objects up to 25 lbs.

Compensation and Benefits

• Pay Range: $32.00 - $35.00
• Benefits information: https://www.tolmar.com/careers/employee-benefits
  
  
  
  • Please note that due to the temporary nature of this position, not all benefits may apply.
  
  
  
  

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.