Associate Specialist, Operations

Merck•Durham, NC

5d•Hybrid

About The Position

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished goods. We have an exciting opportunity for an Associate Specialist to join the Continuous Improvement team for a capital project start-up in Durham, North Carolina. The facility includes end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. This position requires the ability to work independently with moderate supervision, produce/complete various assignments requiring analytical ability, demonstrate independent judgment, creativity and problem-solving skills. This role also requires strong collaboration and communication skills to enable interfacing with both internal contacts (local site level) and external contacts (external customers, above site partners, vendors) to support these initiatives. The Associate Specialist must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation.

Requirements

High School Diploma AND at least Three (3) years in a manufacturing, technical, support, or Military role.
Experience with Project Management and/or indirect leadership.
Demonstrated written and verbal communications skills.
Ability to foster a collaborative work environment.
Demonstrated interpersonal, technical aptitude, and problem-solving skills.
Strong team skills, including the ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict.
Must be flexible and able to manage multiple priorities.
Analytical Problem Solving
Business Operations
Change Management
Communication
Conflict Resolution
Critical Thinking
Fast-Paced Environments
GMP Compliance
Good Manufacturing Practices (GMP)
Internal Customers
Machinery Operation
Manufacturing Operations
Process Optimization
Production Planning
Production Scheduling
Project Controls
Project Facilitation
Project Management
Raw Material Specifications
Regulatory Compliance
Teamwork
Technical Problem-Solving

Nice To Haves

Bachelor’s degree in a technical or science field.
Experience and comfortability working in a group environment.
Understanding of Lean Six-Sigma methodologies.
Experience with shop-floor cGMP manufacturing and related systems (i.e. SAP).
Familiarity with pharmaceutical regulatory requirements.
Project management and data analysis skills.
Technical writing experience.
Experience with facility, equipment and/or process start up activities in a cGMP environment.
Demonstrated ability to work independently.

Responsibilities

Working within the Operations management team to create and execute strategies that support design, development, delivery and evaluation of projects related to steady-state production and/or continual process improvement.
Ensuring visibility and accuracy of the project schedule and update dashboards accordingly to highlight the project status of critical milestones.
Analyzing and implementing initiatives that will help to increase overall success within the department.
Effectively using metrics and measurement to ensure that projects and initiatives result in desired outcomes.
Ability to prioritize workload under guidance from management.
Assist with facilitation of Project and site Tier meetings and help manage the site project portfolio.
Guide cross-functional teams to advance project goals.
Assist in developing project controls and metrics to display the overall health of the project.
Partner with Operational Leadership to implement Continuous Improvement and Lean Methodology implementation.
Develop and implement plans in partnership with other internal departments and above site and external contacts on different projects and initiatives.
Communication skills must be effective to interact with internal/external customers to manage projects, assignments, and workflow.
The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best comprehend and resolve it at the root cause.