Pfizer Sr. Specialist Manufacturing in Kalamazoo, Michigan

ROLE SUMMARYThe successful candidate will assume professional responsibilities within the API (Active Pharmaceutical Ingredient) compliance group. Primary responsibilities include managing all cleaning and process validation activities for their assigned manufacturing areas. In addition, the candidate must interface regularly with customer and regulatory auditors and take a lead role in evolving compliance programs with the API area.ROLE RESPONSIBILITIES:The successful candidate will assume professional responsibilities within the API (Active Pharmaceutical Ingredient) compliance group. Primary responsibilities include managing all cleaning and process validation activities for their assigned manufacturing areas. In addition, the candidate must interface regularly with customer and regulatory auditors and take a lead role in evolving compliance programs with the API area. Key responsibilities include:Develop strategies and documents for cleaning and process validation of API equipment and products in compliance with site SOPs and regulatory guidance.Support 24/7 plant operations with timely responses to complex validation concerns or cleaning failuresDefend the validation programs and strategies to customer and regulatory auditors.QUALIFICATIONS:Education / Experience:High school diploma / general education degree (GED) and 8+ years related experience in Active Pharmaceutical Ingredient Manufacturing (or similar), OR3+ years with Bachelor’s Degree in an accredited program in a relevant Engineering or science discipline.Computer Skills: Microsoft Applications, willingness to learn and utilize SAP, QTS, QPSNTPhysical Demands: Frequent time in the manufacturing area around equipment with moving parts, stair climbing, roof access.Work Environment: Office environment, with frequent time in the manufacturing. Use of hearing and eyeprotection is required.Certificates, Licenses or Registrations: NoneTechnical Writing: Demonstrated ability to write effectively with emphasis on technical content.Regulated Environment Acumen: Understanding of how regulatory standard and guidance documents as well as evolving cGMPS impact pharmaceutical production.Problem Solving and Innovation: Provide solutions to a wide range of difficult/complex problems. May refer to precedents and policies. Able to gather, analyze and interpret information and identify cause and effect relationships. Solutions are imaginative, practical, thorough, and in-line with organization objectives. Able to adapt and respond positively to situations and people in order to meet changing work unit priorities. Identify cost improvement projects. Operate within established HR policies and guidelines.Discretion, Latitude, Level of Independence: Work under only general direction. Participate in determining objectives of assignments. Independently determine and develop the approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives. Administer policies procedures that affect individual colleagues in assigned unit.Impact and Organizational Contribution: Contribute to the completion of specific programs and projects. Ensure that projects are completed on schedule following established procedures and schedules. Erroneous decisions or recommendations or failure to achieve results might cause delays in program schedules and result in the allocation of more resources. Monitor and manage the efforts of colleagues to achieve delivery of short-ter