Specialist Engineering

Job Description

We are seeking a Growth and Improvement-minded Specialist, Engineering that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs.
• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business).
• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape.
• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world.
• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges.

The Specialist, Engineering will serve as a member of the Technical Operations team supporting thaw, pool, and filling manufacturing areas. The Specialist, Engineering is expected to collect and interpret information, to develop solutions and to make decisions with high liability to projects of varying scopes. Very minimal supervision, guidance, and direction are employed by the Associate Director, however, periodic checks and reports are required to review soundness of technical judgment and the status/schedule of the effort.

Primary responsibilities:

This role will collaborate with Operations, Quality, and other support groups to meet targeted manufacturing and compliance initiatives within an Integrated Product Team, and to execute and support key projects for the business including continuous improvement changes and strategic production initiatives. The subject position will be responsible for the following:

• Provides technical assistance to manufacturing operations in the resolution of thawing/pooling/filling equipment problems for in-line products. This involves leading root cause analysis investigations for equipment-related quality events.
• Provides written scientific justification for proposed changes by conducting literature search, designing and executing experiments, analytically reviewing current and past data, and demonstrating the impact of process changes on product quality, production efficiency, or productivity.
• Provides technical assistance for quality and regulatory activities including site inspections, preparation of technical documents for NDA supplements, FDA observation, and environmental process issues.
• Responsible for the accuracy of Process Descriptions and Critical Process Parameter Memos. This requires a thorough knowledge of the Drug Product operations, the hazards involved, and the in-process controls necessary to obtain reproducible results.
• Responsible for completing all process engineering/process development activities with the highest regard for all of our Company Divisional policies and Durham site procedure for safety, quality, and regulatory compliance.
• Review literature pertaining to pharmaceutical aseptic filling and lyophilization in order to introduce new profitable/productivity ideas into the Drug Product operation.
• Provide technical support for the design, machinability evaluation, process performance qualification and qualification of new or modified equipment components
• Supports on shift support during critical manufacturing runs such as Aseptic Process Simulation, protocol execution, and developmental runs
• Responsible for authoring process change controls and completing tasks to implement Drug Product equipment/process changes.

Education Minimum Requirement:

• Bachelor of Science Degree (BS) in Engineering or related fields with two (2) years’ experience in pharmaceutical operations, technical services, or quality operations;

Required Experience and Skills:

• Minimum of 2 years relevant industrial experience.
• Experience working in a GMP Pharmaceutical Environment.
• Demonstrated leadership and teamwork skills.
• Proven communication skills. Strong oral and written communication skills.
• Mechanical aptitude to troubleshoot/resolve equipment issues.

Preferred Experience and Skills:

• Experience in deviation management and/or change control and/or equipment support and/or project support role.
• Experience in pharmaceutical industry.
• Project management skills.
• Experience in writing process change controls.
• Experience in the use of Lean Six Sigma tools. #EBRG´s #VetJobs

Required Skills:

Adaptability, Adaptability, Change Control Management, Change Controls, Collaborative Leadership, Competency Management, Data Analysis, Equipment Designing, Equipment Troubleshooting, Evaluate Information, Good Manufacturing Practices (GMP), Leadership Theories, Lean Manufacturing, Operations Engineering, Organizational Leadership, Personal Initiative, Procedure Writing, Process Definition, Process Optimization, Product Analysis, Professional Integrity, Project Implementations, Project Leadership, Project Management, Project Scoping…