Job Details

Description

Why Patients Need You 

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.  
 
What You Will Achieve 

As a member of the Pfizer Drug Substance and Active Biological Ingredients (ABI) team, you will work with others to be accountable for activities involved in the production of many of Pfizer's products. In your work, you will help to determine the manufacturing methods, procedures and tooling requirements for products, as well as designing the tools and planning production sequences in accordance with continuous improvement, Six Sigma, Lean and other Good Manufacturing Practices (GMP). Your work will help Pfizer in its mission to focus on innovation, creativity and respect for patients, colleagues and society.  

As an Engineer, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.  

It is your dedication and hard work that will make it possible for customers and patients to receive the medicines they need, when they need them.  
 
How You Will Achieve It 

• Spends time on the production floor during critical processes to proactively identify areas for improved efficiencies and ensure that product quality is maintained through all phases of production including operational parameters of manufacturing equipment, automation control, processing dynamics, and integrated utilities to identify and resolve quality, and technical, risk to manufacturing.  Serve as the areas technical SME and develops expertise in various manufacturing operations and processes including automation controls that operate and monitor the processes.
• Requires in-depth knowledge of scientific principles, technical knowledge of production equipment, automation control systems, processing requirements and any related procedural requirements with emphasis on assigned production area.
• Capable of identifying technical problems and solving them with minimal guidance. Ability to analyze operational process issues and automation challenges to recommend/initiate appropriate corrective and preventative actions.  Acts as a departmental liaison with primary support groups such as engineering, technical services, quality control, quality assurance, development, and utilities.   The incumbent will manage / implement process, equipment, and automation changes in support of manufacturing operations.

Key Responsibilities

• Partner with current team to ensure consistency between unit operations and communicate process performance across shifts and departments.  
• Initiate and supports risk assessments, change management and implementation for changes to the manufacturing processes and associated systems.
• POC and regular interactions with the Engineering, Quality, Site Technical Services, and Operational Management departments.
• Support IMEX (Integrated Manufacturing Excellence) utilization and improvement of metrics
• Support of audits (internal and external) including walkthroughs, responses, and driving closure of any observations.

• Primary point of contact for operator support and issue resolution
• Responsible for problem diagnosis/root cause(s) determination (automation, mechanical, documentation, training, etc) and co-ordinate resolution activities.
• Support and contribute to manufacturing investigations and CAPA
• Identifies potential process improvement projects.  Leads and Supports implementation of process improvements projects and supports compliance-driven projects that require technical support.
• Contribute to the development and modifications of operational process and equipment documentation including SOP, Job aid and Master batch records.
• Support Capital projects, and implementation and manage own time to meet the agreed targets. 
• Serve as technical support within your assigned group, collaborating with outside groups as needed. 
• Serve as the operations point of contact for campaign start-up with roles in site and risk assessment, generation of cGMP documentation, area preparation, process execution and summary reporting.   
• Coordinate area clearance and product changeover within manufacturing process. 
• Help in process monitoring including real time review of process parameters and process data/trend analysis.  ?
• Implement process enhancements and measures, and assist with the implementation of new technologies. 
• Conduct skills training and provide subject matter expertise for training materials. 
• Drive continuous improvement in the work processes associated with support of commercial manufacturing and change management.
• Work with network counterparts such as Grange Castle and Sanford in support of any impact or process-related issues.

?Qualifications  

Must-Have 

• BA/BS in chemical engineering, biology, biochemistry or related science or engineering field. Minimum of 3 years relevant experience with an engineering degree or, MS +1 yrs.
• Good verbal communication and ability to coach and provide guidance to others. 
• Computer literate, with skills in Microsoft Applications and process tracking software.  
• Able to work individually and in a team environment. 

Nice-to-Have 

• Master’s degree and relevant pharmaceutical experience ?
• Continuous Improvement or Project Management Certifications. 
• Previous experience in a GMP manufacturing environment
• Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs 
• Familiarity and experience with one of the following unit operations: mammalian cell culture or microbial fermentation, centrifugation, tangential flow filtration, column chromatography. 

PHYSICAL/MENTAL REQUIREMENTS

• PHYSICAL/MENTAL REQUIREMENTS

  Work will include walking throughout the manufacturing suite including up and down stairs.

  Perform mathematical calculations and ability to perform complex data analysis

  Ability to don cleanroom gowning

Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situations

           -Ability to process complex information and make recommendations with incomplete data set

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to adjust work schedule to meet business needs – overtime, off shift, weekends.

Ability to travel– travel time may be up to 10% according to business needs.

Relocation assistance may be available based on business needs and/or eligibility.