Process & Continuous Improvement Manager
The Process & Continuous Improvement Manager role supports operational compliance with current good manufacturing practices (cGMP) guidelines, and federal, state, and local Environmental and Safety regulations. Responsible for operational quality, environmental, and safety incident investigations. The role focuses on both, short-term tasks associated to daily production support and on medium to long range projects of relative high risk and complexity. Facilitates planning and coordinates execution of continuous improvement activities in the manufacturing operations shop floors involving personnel from other functional areas. The role represents the Franklin site in API network projects associated to manufacturing compliance (EHS/Quality) and operational enhancements (IMEx Operating Standards, HOSuN, etc). The role also leads and/or facilitates execution of Capital Projects on behalf of Operations. Role enables Quality and EHS investigations as well as improvements relevant to enhancing the Quality & EHS compliance aspect of the operation.
- Functional/Technical Knowledge: Successful application and demonstration of principles, concepts of discipline. Self-directed & proactive use of technical applications on large scope applications/ projects. Identifies/executes significant process improvements.
- Problem Solving and Innovation: Drives continuous improvement and innovation initiatives for the site. Implements solutions to complex problems through application of 6 sigma problem solving methodology (Black Belt and Green Belt tools) in addition to use of ingenuity, innovation, and creativity. Ability to gather, analyze, and interpret, relate and compare information from multiple sources. Ensures solutions are consistent with organizational objectives.
- Discretion, Latitude, Level of Independence: Performs long term assignments in a self-directed fashion and without appreciable direction from Operations Leader. Exercises some latitude in determining objectives of assignment.
- Impact and Organizational Contribution: Guides the successful completion of major programs for the site and assumes project leadership roles. Contributes to achievement of site and/or API Network goals. Ensures that projects are completed on schedule and within budget. Erroneous decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure of additional time, human resources and funds. Lead and motivate others, generating commitment and a shared sense of purpose. Empower others to contribute their best. Serves as the Operations Department point of contact for the review and approval of cGMP documentation, such as change controls and master batch record revisions.
- Teamwork/Influence: Performs and serves as a coach to others in building the competency of process monitoring and data analysis associated to daily tasks, and to support presentations in several forums including project team meetings. Represents the Franklin site as contact for API Network projects. Leads teams of diverse make-up including cross functional areas and different colleague levels. Interacts with senior internal and/or external stakeholders on matters often requiring coordination between departments and/or above site resources. Conducts briefings and participates in technical meetings concerning manufacturing operations.
- Time Span of Work: Projects and tasks covering short-term (3-6 mo) and long-term (12-18 months) deliverables or milestones; Progress of work measured at milestones.
- B.S. in science or engineering field.
- At least 6-years of operational & technical experience in highly regulated industry.
- Minimum 4-years of cGMP operational experience.
- Chemical or mechanical engineering disciplines.
- Six-Sigma GB or BB certification.
- knowledgeable in IMEx API operating standards.
Mental: ability to work independently, and with minimum supervision on tasks with uncertain outcomes; ability to assess and analyse complex operational & technical tasks and to coach others towards building technical & operational competencies.
Physical: limited lifting, walking, bending in operational shop floors.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Standard Mon-Fri work schedule with sporadic windows of additional work based on business needs. Limited travel (once or twice per year) to another PGS site or off-site training.
Other Job Details:
Last Date to Apply: October 19th, 2021
Eligible for Employee Referral Bonus
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