Pharmaceutical Process Engineer
7 days ago
We are seeking a skilled Pharmaceutical Process Engineer to join our team at NO DEVIATION PTE. LTD.
Job Description- Support and lead projects as an Engineering Technical Lead or Subject Matter Expert for process equipment in new product introductions, change controls, and other qualifications activities.
- Provide technical expertise in site selection assessments, equipment/facility gap analysis, and partner project managers to develop project cost and schedule.
- Perform assessments for equipment during new product introductions, change controls, and other qualifications activities to ensure equipment is in its validated state.
- Subject Matter Expert for process equipment performance and operation to ensure safety, compliance, and sustained operation.
- Lead and participate in technical transfer activities and cross-functional meetings.
- Work independently and/or with project managers to complete engineering projects of various scales within schedule, budget, and quality constraints.
- Effectively manage and work with the project CQV team to ensure timely delivery of projects.
- Responsible for commissioning and qualification activities including FAT, SAT, PSSR, automation checkouts, IQ, OQ, PQ, and asset/preventive maintenance/spare parts creation for new process equipment.
- Doctorate degree in Engineering OR Master's degree in Engineering with 4 years of directly related experience in a pharmaceutical manufacturing site OR Bachelor's degree in Engineering with 8 years of directly related experience in a pharmaceutical manufacturing site.
- Able to work independently with minimal supervision.
- Experience in managing various stakeholders' expectations related to process equipment in biopharmaceuticals.
- Good communication skills, both oral and written, including presentation skills.
- Good interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met.
- Strong analytical skills and knowledge of industry trends to identify potential improvement opportunities.
- Working knowledge of biopharmaceutical processes such as chromatography, buffer/media tanks, viral filtration, tangential flow filtration is preferred.
The estimated salary for this role is between $120,000 - $180,000 per annum, depending on location and experience.
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