Position Summary:

Assist management in an administrative, project management capacity with various aspects of operations enhancement with a focus on equipment purchases/upgrades focusing on manufacturing, packaging, ERP, facilities, developmental activities, and strategic projects to support the growth of the organization.   

Responsibilities: Including but not limited to: 

• Prepare and manage job proposals, integrating all project elements including budgeting, scheduling, and determination of user specification requirements. 

• Coordinate cross functional meetings with in-house management and key stakeholders to provide equipment procurement/facility updates, issuing meeting minutes, and following up on tasks to ensure timelines are maintained.

• Compose and edit relative content for meetings.  This includes but is not limited to presentations, reports, equipment specifications, etc. 

• Meet frequently with executive team members to define User requirement Specifications (URS) for new equipment purchase or equipment upgrades. 

• Work directly with equipment vendors on RFQs and equipment specifications. 

• Coordinate with Facilities Maintenance, Engineering and Validation teams on all activities related to equipment installation, testing, and qualification.  This includes managing required resources and materials for any activities needed. 

• Participate in scheduling and execution of FAT (Factory Acceptance Testing), SAT (Site Acceptance testing) and other testing as required with Engineering team and vendors. 

• Create and maintain project documents (timelines, smartsheets, etc.) for all active projects.

• Work cooperatively and effectively with customers, vendors and team members to set goals, resolve any conflicts, and make decisions that enhance organizational effectiveness.

• Other responsibilities as assigned by management.

Education and Experience:

• Bachelor’s degree with 1-2 years’ experience in manufacturing environment with knowledge on equipment installation and relevant engineering/validation tasks. 

• Strong Knowledge of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), CFR and other regulations as needed.

• Analytical, detail-oriented, and able to prioritize many high-priority projects at one time.

• Well-spoken with excellent written communication skills and a professional demeanor.

Skills and Abilities:

• Excellent oral and written communications skills, working knowledge of MS Office and Project management tools like Smartsheets and MS Project.

• Ability to prioritize, multitask and own projects

• Motivated and detail-oriented, with exceptional organizational skills

• Foster a shared culture of efficiency with importance on meeting project commitments.

• Leadership mentality to help manage and guide projects to successful, on time completion. 

• Ability to negotiate and resolve conflicts.

Work Environment:

• Work environment in production operations facilities include proximity to heavy machinery and pharmaceutical powders.

• Potential to move between production operations sites/areas to complete job functions. 

• Hours/Travel maybe subject to changed based on management/company discretion.

• Standing, sitting, bending, kneeling, picking up or moving boxes up to 50 pounds are part of role.

• For exempt employees, casual or incidental overtime worked is not compensable. When these extra efforts are either infrequent or of short duration, it is expected that exempt Employees will consider these extra hours per day, part of their professional employee/Company relationship and extend their efforts without additional compensation