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Principal Process Engineer: USA Application
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Works as a key technical resource in supporting company objectives with respect to process design and project management. Responsibilities include working with and/or leading the team to help identify, develop and execute projects to meet or exceed all company goals. This could include: developing user requirement specifications, performing risk assessments, developing and or executing development protocols to develop manufacturing, packaging, and cleaning processes. The incumbent provides process support to Operations, ensuring effective and efficient production of products.
This position is also responsible for the development and scale-up of commercial processes from bench through production scale, and the transfer of pilot and commercial manufacturing and packaging technology between sites and for external customers.
In addition, the position is responsible for providing technical leadership with regard to problem solving and process/product improvements in support of current commercial manufacturing and packaging operations. This requires that appropriate and timely investigations, protocols, data analyses, and conclusions are utilized to achieve outcomes, including but not limited to leading task and project teams, writing and reviewing scientifically valid technical evaluations, and ensuring project initiatives will achieve successful outcomes. This position will be responsible for the guidance and utilization of technical staff and departmental resources in achievement of the group’s objectives.
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- MS with 8-12 years of experience, or Ph.D. with 5 – 8 years of experience, in an engineering and or pharmaceutical technology discipline
- Experience must be in the pharmaceutical industry in the area of Engineering, Technical/Pharmaceutical Services, Validation, or Product/Process development.
- Hands on experience with small molecule solids and liquids manufacturing required.
- Strong background in technical troubleshooting, problem solving.
- Detailed knowledge of equipment operation and validation requirements.
- Proficient knowledge of pharmaceutical cGMP requirements and systems.
- Knowledge of regulatory requirements for manufacturing of pharmaceutical products.
- This position requires the ability to think in high level terms to develop technical solutions for new processes. It also requires the ability to think in specific, detailed terms when problem solving for existing processes.
- Ability to foster and maintain an environment of proactive working practices, and effective communication within the group, and between the group and external functions.
- Strong problem solving and investigation techniques.
- Excellent written and oral communication skills.
- Thorough understanding of the drug development process.
- Expertise in Technology Transfer.
- Demonstrated performance in project management.
- Strong organization skills with the ability to multi-task in a dynamic environment and balance multiple priorities.
- Expertise with solid and liquid pharmaceutical manufacturing processes, equipment, and operations.
- Must be capable of working independently, with self-initiative, self-motivation, and self-strategic direction, while also effectively working within team and matrix environment to influence and guide activity.
- Proven ability to work on complex problems and interpret scientific data where analysis requires an evaluation of intangible variables.
- Solid understanding and interprRégionion of Regulatory guidance documents and filing mechanisms.
- Experience preparing and delivering technical presentations.
- Ability to interact with people at all levels of the organization as well as some interaction with government agencies.
Unither is an Equal Opportunity Employer / Affirmative Action Employer
Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet