Process Engineer - Operations/Quality Development Program (Secondment - 12 Months)

Pfizer•Kalamazoo, MI

2d•Onsite

About The Position

This role is a 12-month secondment opportunity designed for high-performing Operations and Quality professionals seeking to broaden their experience and gain meaningful exposure to the partner organization. The intent of this assignment is to deepen cross-functional knowledge, strengthen collaboration between Operations and Quality, and develop future leaders with a strong end-to-end understanding of drug product manufacturing and compliance. This posting is for current Kalamazoo Drug Product Quality Assurance organization who are looking for experience and growth within the Drug Product Operation organization. The successful candidate will be fully integrated into the drug product organization and will perform the day-to-day responsibilities of the role, serving as an active contributor to operational unit, compliance, and continuous improvement initiatives. This is a hands-on assignment with accountability for delivering results while gaining practical experience working across multidisciplinary teams.

Requirements

Must have a bachelor's degree with at least 3 + years of experience; OR a master's degree with more than 1 + year of experience; OR an associate's degree with 6 + years of experience; OR a high school diploma (or equivalent) and 8 + years of relevant experience.
Strong understanding of cGMP and regulatory requirements.
Proficiency in troubleshooting and problem-solving within a manufacturing environment.
Excellent communication and organizational skills.
Ability to work independently and as part of a team.
Experience with process validation and documentation.
Familiarity with environmental, health, and safety standards.
Candidates must be authorized to be employed in the U.S. by any employer.
This position requires permanent work authorization in the United States.

Nice To Haves

Experience in a pharmaceutical manufacturing environment.
Knowledge of Lean Manufacturing principles.
Proficiency in data analysis and statistical tools.
Strong project management skills.
Ability to mentor and train junior colleagues.
Experience with regulatory inspections and audits.
Strong attention to detail and commitment to quality.
Ability to adapt to changing priorities and work in a fast-paced environment.
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.

Responsibilities

Identifies and implements cost savings ideas, specifically line efficiency improvements and other projects that increase equipment capacity.
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.
Support investigations 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.
Serves as customer project manager on equipment purchases or improvements; interface closely with engineering to specify user requirements, review and approve drawings, define project scopes.
Collaborate with other enabling departments (Quality, Engineering, Maintenance, EHS etc.) to assure initiatives are successful.
Lead and participate on teams to address compliance gaps identified through internal and/or external inspection activities.
Provide guidance, coaching, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the division.
Identify and implement cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity.
Incorporate Current Good Manufacturing Practices regulatory and safety compliance into all assigned projects' scope and design.
Support and maintain an audit readiness program for all Drug Product areas and participate in regulatory/internal audits/inspections.