Sr Engineer II - Clinical Label and Pack

Job Description

About This Role

As a Sr. Engineer II at our Research Triangle Park (RTP) facility, you will be essential to our Labeling and Packaging operations for bottles, vials, blisters, and syringes, playing a key role in delivering life-changing therapies to patients. This position offers a unique chance to engage in both the startup and ongoing operations phases, providing a well-rounded experience in pharmaceutical engineering.

The Sr. Engineer II designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process and facility equipment. The incumbent would support technology transfer of new processes into the facility, provide project engineering support as required for new equipment installations and modifications to existing equipment and have the ability to manage medium to large engineering projects with little direction. In addition, they would develop validation protocols, oversee validation testing and final report approvals. This role will work with and provide some direction to contractors and participate in and lead multi-function teams to implement change and improvements on existing processes.

What You’ll Do

• Responsible for supporting manufacturing operations by troubleshooting process equipment system issues and identifying improvements. Update preventative maintenance job plans, equipment standards, drawings and specifications as necessary.
• Provide engineering technical support and troubleshooting for plant utilities and facilities systems. Participate in multi-functional teams to implement changes and improve on existing processes
• Provide responsible engineering and validation support for process and utility systems. Specifically design and develop validation protocols, provide expertise to associated equipment and automation design / modifications, support FAT (Factory Acceptance Testing), equipment startup, & commissioning efforts, as required.
• Identify and lead process equipment related projects, including technology transfers, capital projects, and modifications. Provide input & guidance to Tech Transfer and area efforts, provide technical evaluations of process equipment including validation requirements for change controls and associated action plans.
• Provide support with presenting discussion topics during health authority (e.g. – FDA) and partner inspections with regards to engineering and validation practices and policies.

Who You Are

You are an experienced equipment engineer who likes to troubleshoot and investigate improvements to increase site operations and passionate about learning new technologies and working in a cross-functional environment. You are accountable for achieving milestones in equipment projects and are passionate about making a difference and have a strong desire to contribute to a mission-driven organization. You thrive in a fast-paced environment and are eager to learn and grow. Your adaptability and attention to detail make you a valuable team player in the complex field of biomanufacturing.

Qualifications

• Bachelor's degree in engineering.
• Minimum of 6 - 8 years of experience in process equipment engineering, preferably in a biologics pharmaceutical environment.
• Experience with pharmaceutical process equipment or production facility operations required.
• Practical knowledge and application of GMP regulations and guidelines (ISPE, USP, PIC/S, Annex, ICH, etc.). Competency in DeltaV, MS Word, MS Excel, MS Power Point and MS Project.
• Excellent organization, time management, oral and written communication skills.
• Ability to work on-site and on-call, extended coverage support, and weekends as needed.
• Strong communication skills (both verbal and written) and ability to work as part of a team.

Additional Information

The base salary range for this position is $104,000 - $139,000. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-