Use Your Power for Purpose

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.

What You Will Achieve

Provide engineering and technical subject matter expertise related to the evaluation, technology transfer, startup, and qualification of new and existing equipment, facilities, and utilities in support of new product introduction. This may include production equipment such as bioreactors, ultrafiltration skids, Clean – In – Place (CIP) skids, chromatography skids, and other support equipment.

• Responsible for the introduction of new products into an existing biopharmaceutical facility

• Perform new product facility fit assessments including equipment selection and sizing and utility usage estimates

• Develop tech transfer and product changeover scopes of work and work with planners and schedulers to plan and implement the work

• Execute the design, commissioning, and qualification of improvements, changes, or upgrades to this equipment as needed

• Develop validation and qualification plans, protocols, and summary reports

• Perform component, equipment, and process improvement projects as needed

• Participate in implementation of PLC, HMI, and database configuration changes

• Engage with vendors/manufacturers to procure equipment, components, and manufacturing instruments

• Perform planning and scheduling through development of process models using Schedule Pro

• Identify and implement improvements to reduce product changeover time in the suite

• Identify and support long term capital projects to improve new product introduction efficiency

• Provide on the floor operational support as needed

• Provide off-shift and on call support when necessary

• Apply technical expertise in Operations, Quality, and Validation to recommend improvements considering business challenges.

• Lead cross-functional project teams through high-risk technical assessments and develop complex engineering solutions.

• Provide guidance and lead moderately complex projects, managing time and resources effectively.

• Apply skills and discipline knowledge to contribute to departmental work and make decisions to resolve moderately complex problems.

• Work independently, review own work, mentor colleagues, and exercise judgment utilizing knowledge and experience.

Here Is What You Need (Minimum Requirements)

•  Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of
  relevant experience

• Relevant experience in biopharmaceutical industry

• Knowledge of Good Manufacturing Practices and experience in Pharmaceutical environment

• Candidate must be able to work across functional areas such as operations, technical services, maintenance, quality and regulatory

• Knowledge working with computers and associated applications such as MS Word, Excel, and PowerPoint

• Broad knowledge of theory and principles within the engineering discipline

• Strong technical, management and organizational skills

• Good leadership and communication skills

• Ability to solve complex problems

• Ability to locate information and utilize available organizational knowledge to develop innovative solutions

• Strong technical writing skills

• Strong history of problem-solving skills, project and task management skills

• Ability to manage priorities and lead others under pressure

Bonus Points If You Have (Preferred Requirements)

• Knowledge of database applications and Delta V, Allen-Bradley PLC, GE iFix and iHistorian

• Experience authoring, reviewing, and approving User Requirement Specifications, Functional Specifications, and Configuration Specifications

• Knowledge of the manufacturing process and equipment, preferably bacterial fermentation and purification processes

• Experience Commissioning, Validating, and Qualifying new or existing equipment

• Experience with GMP Change Management

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