Project Manager-Technical Operations and Validation

About the job

The Tech-Ops Project Manager is responsible for project management activities for the two Fagron Sterile Services Wichita, KS facilities. The Tech-Ops project manager provides leadership, coordination and management of critical projects from a design, implementation, delivery & qualification perspective. The successful candidate will also be responsible for operational integration of new & existing products, including tech transfers, and automating process into our state of the art, aseptic facility. The Project Manager will be required to interface with, and at times, influence intradepartmental business partners including: Quality Assurance, Engineering, New Product Development, Supply Chain, Manufacturing and Validation. This includes managing projects cross-functionally with input from subject matter experts. The successful candidate will be responsible for managing project timelines, communicating both at a working team level and to senior leadership, maintaining a list of project risks and mitigations, and facilitating meetings.

• Work closely with SME’s to develop project plans, risk mitigation strategies and timelines/milestones
for key projects.
• Interfaces with functional group leaders including Engineering, Manufacturing, Quality Control, New
Product Development, Validation, Quality Assurance, and Supply Chain to ensure aligned strategies,
timelines, etc.
• Coordinate and manage project meetings, including agendas action items and minutes. Ensure
project objectives and progress are monitored and communicated effectively to ensure adherence to
project plans.
• Identify and report on project progress identifying issues and risks and offering viable solutions and
opportunities as they arise.
• Leads meetings with workstream leaders and set expectations for project teams.
• Utilize continuous improvement principles and methodologies to; identify and evaluate opportunities
to improve key performance indicators in the production environment such as, but not limited to:
batch yield, process cycle times, financial standards, waste & fall-off scrap, and repeat deviations
• Establish budget baseline and initiates project financial tracking.
• Monitor the project budget and maintains all milestones in alignment with site Project Review Board
so that appropriate invoicing and revenue recognition can be accomplished in a timely manner.
• Establish full project plans, including timeline, critical path assessment, risk assessment, contingency
planning, mitigation planning, communication planning, contact listing, and confirm scope capture
during planning phase of a project.
• Monitor and control changes to the project scope. Communicate scope changes to all project
• Create schedule baselines and monitor schedule adherence. Communicate slippage and ensure
alignment with schedule changes.
• Work closely with site Tech-Ops team and leadership to manage and prioritize project resources in
support of Fagron’s deliverables and deadlines.
• Help drive a project culture by teaching and coaching project management tools and techniques to
others within the organization.
• Manage personal time off by requesting the time off in company time keeping system for either PTO
or VPTO according to company policy for salary employees. See company handbook for policy details.

Set yourself apart

• The successful candidate must embody and be personally responsible for aligning with Fagron’s
values of; speed of execution, innovation and entrepreneurship while focusing on core quality & safety
• Bachelor's degree from an accredited college/university (a degree in life sciences, engineering or
medically related field is preferred), Project Management Professional (PMP) certification or similar
formal project management training is a plus.
• Minimum 5 years project management experience with 3+ year’s relevant experience in
biotechnology, life sciences, pharmaceutical or medically related field is strongly preferred.
• Experience in working in a cGMP environment, with FDA & State Board of Pharmacy experience is
• Demonstrated experience in complex strategic planning, project execution, and resource
management for a global organization is desirable.
• Experience in successfully coordinating across several complex functions to ensure comprehensive
and consistent planning.
• Proficiency in project management principles, practices, and tools such as MS Project (Gantt charts) is
• Experience with the preparation of reports and/or presentations/communications via presentation
tools such as PowerPoint, project dashboards and written reports.
• Experience in drug product development, quality systems, and/or validation experiences within the
pharmaceutical or biotech industry is preferred.
• Strong business acumen.
• Relevant IT skills (able to work with Visio, Microsoft Project, PowerPoint and Excel).
• Ability to think strategically and tactically (detail-oriented).
• A demonstrated history of strong collaborative and influencing skills, and ability to work well in a
cross-functional, matrixed environment.
• A demonstrated history of strong analytical and problem-solving skills.
• A demonstrated history of strong written and oral communication skills.
• Experience with meeting management / facilitation skills / teamwork and team building skills.
• Ability to manage and prioritize multiple projects simultaneously.
• A demonstrated ability to move seamlessly between project leader and project team member
(individual contributor) as needed.
• Flexible and able to adapt to company growth and evolving responsibilities.

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