Mgr Professional/ Proc Engineer - MAP Mod 1

Pfizer • Kalamazoo, MI

3d • Onsite

About The Position

USE YOUR POWER FOR PURPOSE ROLE SUMMARY Provides technical expertise and operational support for Drug Product Operations and specifically the new Modular Aseptic Processing (MAP) Mod 1 facility. This position will support the capital project from an Operational Readiness standpoint in Formulation and Dispensing workstream. This will include partnering with OEM vendors, automation, engineering, verification, and quality to ensure the facility meets operational, quality and EHS requirements. The position will transition to an operations support role after regulatory approval. Partners with shop floor colleagues and supervision to ensure smooth and efficient production of a diverse mix of products. Assists in equipment troubleshooting activities as needed. Serves as a subject matter expert within the site for highly automated aseptic formulation and dispensing systems. Responsible for technical development of junior colleagues. Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring that customers and patients receive the medicines they need, precisely when they need them. By collaborating with our forward-thinking engineering team, you will contribute to delivering medicines to the world at an accelerated pace by envisioning new possibilities and taking decisive action. Your role in the design and development of manufacturing processes, as well as in maintenance and reliability support, is essential for providing timely access to necessary medications. Working alongside our innovative team, you will help expedite the delivery of medicines globally by imagining what can be achieved and making it happen.

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.
• Demonstrated experience in product development, manufacturing science and technology, sterilization or process validation, or Process Engineering within the pharmaceutical industry.
• Thorough knowledge of cGMP (current Good Manufacturing Practices), combination device regulations, and design control.
• Strong history of problem-solving skills, project and task management skills.
• Ability to manage priorities and lead others under pressure.
• Strong verbal and written presentation communication skills.

Nice To Haves

• Relevant experience in the pharmaceutical industry.
• Proven ability to work collaboratively in a cross-functional team environment.
• Strategic planning and forecasting skills.
• Ability to facilitate agreements between various teams.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.
• Specific knowledge of and experience with Drug Product processing and equipment in highly automated aseptic preparation, formulation, filling, isolator, or lyophilization systems is highly desirable.

Responsibilities

• Develop User Requirements for OEM equipment and highly automated systems.
• Support capital project from an Operational Readiness standpoint to include Verification and Testing support, SOP development, Training, and IMEx deliverables.
• Develops and validates manufacturing processes for drug products, taking into consideration problems inherent in the transfer of technology from research to production, from other sites, or within the site.
• Collaborates with and influences other enabling departments (Quality, Engineering, Maintenance, etc.) to assure initiatives are successful.
• Develops and validates manufacturing processes for drug products, taking into consideration problems inherent in the transfer of technology from research to production, from other sites, or within the site.
• Conducts tests and measurements throughout stages of production to determine control over applicable variables.
• Investigates deviations that occur on the manufacturing floor.
• Performs root-cause analysis and identifies appropriate, effective corrective actions.
• Implements corrective actions in conjunction with the appropriate enabling groups, i.e. engineering, maintenance, quality, validation, environmental health and safety.
• Leads technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization.
• Provides concise and thorough updates on initiatives to site leadership.
• Mentors junior level colleagues inside and outside of department.
• Provide comprehensive testing and technical support for new manufacturing facilities and processes.
• Facilitate and manage process and component improvement projects as needed.
• Assess, manage, and report on the process capabilities of operational equipment and services.
• Oversee and conduct supplier technical audits and corporate audits.
• Actively share knowledge within the team through established systems.
• 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 tocontribute 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.

Benefits

• eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program
• comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments
• Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees