Sr Engineer II, Manufacturing

Job Description

About This Role

This role designs, specifies and installs new equipment and provides engineering technical support and troubleshooting for assigned process equipment and area assets.  Responsible for leading, tracking, and coordinating activities related to the GMP manufacturing process equipment. Provides project engineering as required for new processing equipment installations and modifications to existing equipment. Aids in the development of junior engineers as appropriate. Able to manage small to medium engineering projects with little direction. Work with and provide direction to contractors. Lead multi-function teams to implement change and improve on existing processes locally and globally.

What You’ll Do

• Support Manufacturing operations by troubleshooting issues and identifying equipment system improvements. Updates standards, drawings and specifications as necessary.
• Identify and lead equipment related projects, including technology transfers, capital projects, and modifications. Complete project management tracking of deliverables for metrics & reporting. Provide input & guidance to Tech Transfer and project / area efforts, provide technical evaluations of validation requirements for core change controls & associated action plans.
• Author sections of Validation-related reports & project plans, approve Trackwise-generated workflows (deviations, global change controls) for equipment / automation-related changes, reviews automation protocols, & attends related meetings.
• Coordinate Equipment/Cleaning Validation Protocols (development, training, management, tracking) - include time spent on production floor. Specifically design & develop validation protocols, provide expertise to associated equipment & automation design / modifications, support FAT (Factory Acceptance Testing), equipment startup, & commissioning efforts, as required. 
• Maintain personal training, goal development / completion, compliance workflow tracking, & progress tracking.
• Represents Engineering department on various industry societies and forums (e.g. – ISPE, BioPhorum)
• Ensures effective communication of validation strategy, risks, and overall plans to leadership and teams.
• Represent engineering and validation systems, data packages and submissions in regulatory audits including responses to any observations.
• Lead validation lifecycle management of validated equipment including regulatory questions / requests of validated systems. Authoring and management of Validation Master Plan and Cleaning Strategy documents.

Who You Are

You are accountable for achieving milestones in equipment projects, involving frequent internal and external communication. As a representative of the Manufacturing Engineering organization, your role carries the weight of potential delays and extra resource allocation if errors occur in your decisions or recommendations. Your commitment lies in delivering accurate and timely results, ensuring efficient processes to prevent setbacks.

Qualifications

• Bachelor's degree in engineering.
• Practical knowledge and application of GMP and EMA regulations.
• 6-8 years of direct engineering and validation experience on manufacturing equipment in a pharmaceutical or biotech environment.
• Competency in Process Controls and Distributed Controls Systems, MS Word, MS Excel, MS Power Point and MS Project.
• Excellent oral and written communication skills.
• Ability to work rotating shifts, extended shifts and weekends as needed.
• Experience with either Fill Finish, Isolator (Bausch and Stroebel) and Lyophilizer technologies preferred.

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-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown