Sr. Engineer II, Mfg Sciences; Parenteral Filling

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As a member of Manufacturing Sciences within the Parenteral Filling area, the Sr. Engineer II will provide technical expertise to the clinical and commercial manufacturing campaigns run at the Pharma Site. The focus of this position will be as a key leader for investigations and project implementation for Manufacturing Sciences using their technical expertise on fill/finish, visual inspection, and packaging.

• Provide technical expertise to the clinical stage, PPQ, and commercial manufacturing campaigns run at the site.
• Lead Process & Technology Transfer teams, technical improvement projects, and technical process investigations as needed.
• Provide technical and operational guidance to Manufacturing during GMP campaigns.
• Lead technical investigations towards process impact assessments and ensure timely completion and communication.
• Author Manufacturing and Process Performance Qualification validation protocols and technical reports.
• Lead small teams on technical projects towards improved facility capabilities, efficient systems, improved technical competency, or increased process/scale-up understanding. Cultivate continuous improvement environment within the process transfer teams at the RTP site and benchmark tech transfer best practices both internal and external to Biogen, as appropriate.
• Be the Subject Matter Expert to support inspections and audits.
• Lead process investigations while servicing as the point of contact to broader organization.
• Perform data analysis to support process improvements or process transfers. Manage technical projects providing value to the Pharma site.
• Facilitate meetings with various stakeholders and communicate to management on the status of programs.

You are a proactive and detail-oriented individual who thrives in a collaborative team environment. Your communication skills help you effectively lead technical projects and engage with cross-functional groups. You have a strong analytical mindset and are comfortable working with scientific datasets. Your independence and ability to manage multiple priorities make you an asset to the organization. You bring a keen understanding of industry standards and regulations, ensuring compliance and driving continuous improvement.

• Bachelors degree in Engineering or relevant scientific/technical discipline with at minimum 6 years of relevant experience is required OR
• Masters degree in Engineering or relevant scientific/technical discipline with at minimum 4 years of direct experience OR
• Ph.D. in Engineering or relevant scientific/technical discipline with at minimum 2 years of direct experience
• Good communication and project management skills appropriate for leadership of tech transfer projects.
• In-depth knowledge in technical understanding of Parenteral Filling Operations (e.g. Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities.
• Excel at working in a team environment
• Comfortable analyzing scientific datasets/analytical skills with excellent written skills
• Ability to work independently and support a large cross-functional group
• Knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, Continued Process Verification
• Ability to work weekends and be on call.

Job Level: Management

The base compensation range for this role is: $-$

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 time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where…