Responsibilities: Essential Duties
- Leads a team of technical engineering subject matter experts and day to day maintenance supervisors/managers to support manufacturing operations CAPS twenty-three sites (503A/B) and serves as a key member of the CAPS Technical Services leadership team.
- Directs and aligns the activities to achieve manufacturing goals and objectives in support of the S&OP plan.
- Establishes metrics as required to measure and track performance related to rate, quality and yield.
- Directs all Technical functions within the business unit to support ongoing manufacturing operations including controls and automation, continuous improvement efforts, optimization of existing processes and troubleshooting and resolution of manufacturing issues.
- Responsible for deviation reports, root cause analysis, engineering studies, and investigative reports. Develop and execute strategic plan to achieve short- and long-term business objectives.
- Supports Equipment Engineering to establish specifications for new equipment or modifications associated with improvement of existing equipment at twenty-one 503A sites and two 503B sites.
- Works collaboratively with operations in establishing the equipment requirements needed to deliver against the site operational goals and objectives including process validation.
- Oversees scheduled maintenance and as needed repair of buildings, grounds, or associated systems and equipment.
- Solicits bids, selects contractors/subcontractors and negotiates bids for the renovation of facilities, construction, etc.
- Provides support and expertise to Director of Pharmacy, Quality and other functional work teams related to the physical requirements and operation of CAPS sites in compliance with Federal and State regulations, as well as current USP<797> and cGMP guidance.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.
Expertise: Knowledge & Skills
- Requires breadth of organizational, professional field, and industry knowledge. Ability to integrate critical information from several diverse areas. Champions advanced strategies and concepts.
- Directs the activities of a broad functional area through division heads who are responsible for planning, budgeting, costs, methods and employees. Determines actual organizational structure and allocation of resources.
- Judgement is required in resolving complex problems based on experience.
- Represents the organization as a prime contact on projects and departmental operations. Interacts with senior internal and external personnel on issues often requiring coordination across organizational lines.
Expertise: Qualifications -Education/Experience/Training/Etc
Required:
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
Physical Demands:
While performing the duties of this job, the employee is expected to:
Lifting, Carrying, Pushing, Pulling and Reaching:
- Occasionally: Reaching upward and downward, Push/pull, Stand
- Frequently: Sit
- Constantly:N/A
Activities:
- Occasionally: Handling, Push/pull, Reaching upward and downward
- Frequently: Seeing - depth perception, color vision, field of vision/peripheral, Standing, Walking
- Constantly: Hearing - ordinary, fine distinction, loud (hearing protection required), Sitting , Talking - ordinary, loud/quick
Environmental Conditions:
- Occasionally: Proximity to moving parts
- Frequently: N/A
- Constantly:N/A
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Noise Intensity:Moderate
- Occasionally: Production/manufacturing environment, Warehouse environment, Lab environment
- Frequently: N/A
- Constantly: Office environment
#IND123
