Senior Process Engineer jobs in United States
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Pharmaron · 6 hours ago

Senior Process Engineer

Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. They are seeking a Senior Process Engineer to join their Coventry, Rhode Island team, focusing on process design, scale-up, and technology transfer in pharmaceutical manufacturing.

BiotechnologyChemicalPharmaceutical

Responsibilities

Support technical transfer of new processes from concept through product delivery, including
Define scale and equipment fit of new processes within existing facility
Design and install new equipment and/or existing equipment modifications to support new process requirements
Manage process safety concerns with accountability for PSM implementation using existing Coventry procedures (thermal hazards, relief design, PHA, etc.)
Perform qualification and validation activities according to site master plan
Generate project documentation and provide training to affected personnel
Assist with project management activities
Use engineering expertise to assist in the execution of capital and expense projects for at the Coventry site
Provide technical support for other Coventry functional groups, including
Support during production activities to solve issues and help ensure safe and compliant execution of process procedures. On-call support will be required during new process start-ups
Generate and own change controls, quality events, CAPA, etc. within the Coventry quality system to support on-going production
Participate in team safety meetings and complete engineering related action items
Support administration of engineering document repository (AutoCAD Vault)

Qualification

Chemical EngineeringCGMP ManufacturingProcess Safety ManagementBatch ManufacturingProject EngineeringProcess EngineeringCollaborationProblem Solving

Required

BSc in Chemical Engineering or a related discipline
Hands-on experience in small molecule API manufacturing, ideally within a CDMO or innovator environment
Strong background in batch manufacturing, with exposure to a wide range of unit operations and associated process equipment
Proven cGMP manufacturing experience, with a solid understanding of FDA regulations and quality standards
Experience across both project engineering and process engineering functions
Working knowledge of OSHA Process Safety Management (PSM) requirements and other relevant safety and environmental regulations
A good balance of chemical process understanding and GMP expertise, with the ability to apply both effectively in a manufacturing setting

Benefits

Insurance including Medical, Dental & Vision with significant employer contributions
Employer-funded Health Reimbursement Account
Healthcare & Dependent Care Flexible Spending Accounts
100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
401k plan with generous employer match
Access to an Employee Assistance Program

Company

Pharmaron

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Pharmaron is a contract research organization that offers research and development services for the life science industries.

Funding

Current Stage
Public Company
Total Funding
$907.82M
Key Investors
GL Capital
2019-11-22Post Ipo Equity· $587.82M
2019-01-28IPO
2015-12-14Series Unknown· $280M

Leadership Team

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Katherine Lee
Chief Business Officer
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Company data provided by crunchbase