Process Engineer: Industrial Operations Specialist
vor 1 Monat
Key Responsibilities:
- Collaborate with external partners to achieve business goals and foster a unified culture.
- Lead technical operations and serve as the primary interface on technical issues between internal and external partner drug substance manufacturers.
- Oversee technical transfer activities, authoring and reviewing GMP documentation, and regulatory filings as needed.
- Manage technical aspects of commercial manufacturing processes at external partners, including change control, process improvement projects, statistical analysis, and atypical event investigations.
- Develop innovative solutions to complex technical challenges.
- Provide on-site support at external partner facilities for commercial and tech transfer activities.
- Translate GMP requirements and current regulations into standardized work processes, partnering with operations, quality, and external partners.
- Ensure external partners are inspection-ready for routine and new product introduction/transfer inspections, in collaboration with operations, quality, and regulatory teams.
- Participate in creating, sharing, and adopting best practices and business process strategies.
Requirements:
- Bachelor's degree in chemical/biochemical engineering, pharmaceutical science, or a related field.
- At least 3-5 years of experience in a GMP functional area or support role, such as operations, technical operations, technology, or engineering.
- Excellent command of English (written and oral communication).
- Ability to work independently and possess strong organizational skills.
- Strong professional and interpersonal communication skills.
- Ability to multitask and work under tight deadlines.
- Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation.
- Proven team building skills.
What We Offer:
This is a high flexibility role with the possibility to work 100% remotely. A willingness to travel (approximately 25%) is required.
This is an excellent project to join a well-known and prestigious pharmaceutical company with an extension option.
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