Principal Process Engineer Rochester United States,
UNITHER Pharmaceuticals (company)
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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.
- SPECIFIC SKILLS:
- 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 interpretation 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
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