Weekend Process Engineer I, II, & III jobs in United States
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Jubilant Pharma Limited · 2 weeks ago

Weekend Process Engineer I, II, & III

Jubilant HollisterStier LLC is a well-established member of the business community in Spokane, Washington, providing a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Process Engineer I/II/III role involves managing pharmaceutical processes and technical transfers, engaging in projects, and providing technical direction while ensuring effective communication across teams.

Health CareManufacturingPharmaceutical

Responsibilities

Design, optimize and implement site manufacturing processes to improve efficiency, quality and sustainability
Oversee and assess existing processes and workflows
Establish and track process metrics to monitor process stability and discover areas for improvement
Technical Transfer of new products from both internal and external clients
Ownership of product process from initial quote to product retirement
Evaluate incoming processes for robustness, efficiency and fit within JHS-Spokane
Perform appropriate development work to define CPPs and CQAs to allow strong execution upon transfer to Manufacturing
Author validation study documents that demonstrate manufacturing processes are capable of consistently making acceptable product
Develop and execute validation studies to test and qualify new and improved manufacturing processes
Troubleshooting, oversight and/or sampling of events within Manufacturing will require occasional off-shift at-location support
Generate reports summarizing results of studies to document data collected; utilize data obtained to qualify site processes
Review data summaries generated by other departments, assess the data for potential trends or conditions that may adversely impact the quality of the sterile products being manufactured, and ensure that corrective action measures are implemented when required/warranted
Participate in or perform deviation investigation and evaluation of impact
Implement effective CAPAs
Responsible for optimizing gross profit margin and minimizing deviation rate
Provide necessary reviews for regulatory and client audits and provide responses to audit observations
In-depth understanding of cGMP’s, European regulatory requirements, relevant USP chapters, and scientific principles associated with clean room operations and room classifications as they apply to media fills, sterilization and depyrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control

Qualification

Pharmaceutical experienceStatistical AnalysisProject ManagementLean Manufacturing PrinciplesMicrosoft OfficeTechnical DirectionLeadership ExperienceCommunication Skills

Required

A Bachelor's of Arts or Science with a major in Biology, Chemistry, Physics, or Engineering is required
0 to 5 year(s) related Pharmaceutical experience or FDA regulated Industry Experience is desired
Master's Degree counts as 2 years' experience desired
Project Management experience desired
Statistical Analysis experience desired
Microsoft Office experience required
Extended periods of sitting or standing required
Ability to lift 40 lbs. unassisted required
2 to 5 year(s) related Pharmaceutical experience or FDA regulated Industry Experience required
Supervisory or other Leadership Experience desired
3-7 years related Pharmaceutical experience or FDA regulated Industry Experience required
Supervisory or other Leadership Experience desired
Project Management required

Preferred

Lean Manufacturing Principles

Benefits

Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
Life, AD&D, Short and Long Term Disability
401(k) with company match
Generous paid time off plan
Employee Assistance Program

Company

Jubilant Pharma Limited

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Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to our customers across geographies.

Funding

Current Stage
Late Stage
Total Funding
$400M
Key Investors
Standard Chartered Bank
2022-07-13Debt Financing· $400M

Leadership Team

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Arun Duggal
Jubilant Pharma
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Company data provided by crunchbase