Pfizer Process Specialist in Kalamazoo, Michigan

The Process Specialist assures compliant manufacturing procedures, equipment, and facilities across the Drug Product plant in adherence with cGMP requirements, Quality Standards, and other regulatory requirements. This position works closely with the Quality organization and acts as a subject matter expert for compliance across the Drug Product organization.Responsibilities•Identify, support, and drive compliance initiatives, drive implementation in Drug Products•Ensure consistent approach to compliance across units within in Drug Products•Compliance Subject Matter Expert for facility and equipment upgrades•Compliance Subject Matter Expert for daily production•Support and drive projects intended to reduce risk, eliminate deviations, and maintain highest product quality•Support audits•Must be change agile and flexible in support of a large manufacturing operation with diverse production needs.Additional Duties and Responsibilities Include:Functional/Technical Knowledge: Knowledge of applicable technical standards, techniques, principles, theories, concepts, production processes, and industry practices/standards. Knowledge of basic leadership principles. Focus is on leading/overseeing defined processes.Problem Solving and Innovation: Provide solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance. Operates within established HR policies and basic colleague relations guidelines.Discretion, Latitude, Level of Independence: Works under general supervision. Follows established procedures. Recommends actions. Work is reviewed for soundness of judgment, overall adequacy and accuracy. Administers policies procedures that affect individual subordinate colleagues and assigned unit only.Impact and Organizational Contribution: Contributes to the completion of specific team objectives and assigned project milestones. Failure to achieve results may cause delays in completion of departmental program objectives. Monitors and manages the efforts of subordinate colleagues to achieve delivery of short-term goals.Teamwork/Influence: Primarily interactions are with on-site colleagues, but there will be occasional off-site interactions. Potential for global support on an as needed basis. May represent department on specific intra-Pfizer projects. May assist in training less experienced team members.BA/BS in a science or engineering related field or equivalent experience.Pharmaceutical or manufacturing experience and strong, leadership skills exhibited in a cGMP environment are desired. Specific knowledge of and experience with Drug Product processing and equipment is highly desirable. Successful candidate must be familiar with tools and techniques required to implement compliance projects through multi-disciplinary teams.Required technical competencies include:•Knowledge of Regulatory, Company and Industry Regulatory Standards•Strategic Planning•Decision Making•Presentation Skills•Coaching Facilitation•DMAIC, Method 1, human error reduction tools•Leadership skills, communication skills (both written and oral), and ability to interact effectively with all levels of the organization is required.•Knowledge of GMP requirements, Quality Standards, and other regulatory requirements is necessary.•Must be self motivated and willing to learn new and changing responsibilities.EEO StatementSunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and sta