Senior Process Engineer - Pharmaron

Position: Senior Process Engineer

FLSA Status: Exempt

Location: Coventry, Rhode Island

Salary: $110,000-130,000

Pharmaron is thrilled to invite you to join us as Senior Process Engineer for our Coventry, Rhode Island site! If you're looking for a role that offers challenges, growth, and meaningful impact, then this is the opportunity you've been waiting for.

Job Overview:

The Senior Process Engineer in the Pharmaron Coventry Manufacturing Technology Team has the responsibility to design, install, and implement processes and equipment supporting GMP production of small molecule active pharmaceutical ingredients (APIs) in a safe, compliant, and efficient manner.

The Sr. Process Engineer must be able to apply technical leadership skills across a broad range of engineering challenges in support of small-molecule API manufacturing. Critical to the success of this position is adherence to cGMP and OSHA Process Safety Management (PSM) regulations while implementing robust production processes and designing efficient, multi-purpose chemical processing equipment.

Responsibilities:

• Provide advanced engineering support for the technical transfer of new chemical processes from concept through product delivery, including calculation of mass and energy balances, equipment selection, unit operation modeling, and generation of manufacturing batch records, protocol, and associated GMP production documents.
• Design and install new chemical process equipment and/or modifications to existing equipment supporting new process requirements or new site manufacturing capabilities.
• Interface with internal project management and external clients during project meetings to effectively communicate project status, maintain adherence to schedules, and solve technical challenges.
• Manage process safety risks with team-based accountability for PSM implementation using existing Coventry procedures for evaluation of thermal, explosion, and electrostatic hazards, vent sizing, process hazard analysis, etc.
• Provide engineering support during new manufacturing start-up to effectively solve production issues, ensuring safe and compliant execution of process procedures. On-call support will be required during new process start-ups.
• Generate and own completion of change controls, quality events, CAPAs, and GMP documentation within the Coventry electronic quality and document management systems to support on-going production.
• Provide technical leadership and guidance to less experienced engineering staff in the Manufacturing Technology group during the execution of engineering projects.
• Lead equipment qualification and process/cleaning validation activities according to site validation master plan and internal procedures.
• Maintain accurate engineering files through the creation, revision and approval of electronic drawings, requirements, specifications, operating manuals, etc.
• Interface with technical resources based at other Pharmaron manufacturing sites to establish best practices and/or bring new manufacturing technologies to the Coventry facility.
• Provide owner direction to contract resources towards completion of engineering and/or construction projects at the Coventry site.

What We're Looking For:

• Bachelor of Science Degree in Chemical Engineering or closely related field with 7+ years of experience.
• Experience in manufacturing and/or process engineering associated with pharmaceutical ingredients, specialty, or fine chemicals.
• Batch chemical manufacturing experience with a wide variety of unit operations and chemical process equipment.
• Experience executing engineering design projects and/or manufacturing operations under cGMP.
• Familiarity with FDA regulations, OSHA PSM standard, and other relevant codes and regulations.
• Excellent verbal and written communication skills to facilitate interaction with clients, regulators, external vendors, etc.
• Experience in project engineering preferred, but not required.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:

• 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

How to Apply:

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.