Manufacturing Weigh and Dispense Lead

Overview: Summary: The Manufacturing Weigh and Dispense Lead will work directly with a range of technologies.
The Weigh and Dispense Lead level provides an opportunity to stay on the technical track, or work towards a supervisory path.
Dependent upon assignment, the range of technologies may include any of the following: Centralize Weigh and Dispense Area: Weighing of raw materials per formulation record specifications and assignment of appropriate expiry per procedures.
Schedule and plan with the Support Scheduler/Planner to coordinate weighed materials.
The Manufacturing Weigh and Dispense Lead is responsible for the safe and efficient operation of materials movements and material storage within the Site storage areas on FDBT.
Lead the start up activities on the centralize weigh and dispense area to support FDBT Manufacturing.
Those activities include but are not limited to weigh and dispense equipment readiness (installation and validation) SOP development and training.
Including purchasing, inductions and set up of the new equipment’s.
Leading technicians from FDBT Manufacturing Areas Solution Preparation in coordination with the supervisors.
Perform all work in a safe and compliant manner.
Consistently follow Standard Operating Procedures (SOP's) and departmental policies.
External US: Essential Functions Include: Write and review standard operating procedures, buffer formulation records.
Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs.
Maintain the confidentiality of proprietary company information.
Document and maintain activity records according to cGMP regulations and ensure junior team members are trained.
Operate general production equipment such as Autoclaves, Analytical Scales, pH/conductivity meters, etc.
Lead/Perform daily cleaning and sanitization of the weight and dispense area and manufacturing.
Maintain an effective working relationship with others.
Perform all other duties as assigned.
Support as required the preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs.
SAP: Extensive experience in, and use of, the validated SAP system and handheld barcode scanners to create transactions in real time.
This includes the following: SAP transactions i.
e.
goods issue, goods receipt, goods transfer.
Receipt & lot numbering of incoming materials.
Issue of materials to process orders and cost centers.
Transfer of materials from locations via barcode system or keyboard.
Confirmation of transfer orders.
Cycle counting and reconciliation of adjustments to and from inventory.
Creating labels for use in dispensing via the barcode system.
Manufacturing Weigh and Dispense Lead: Successfully leads two or more projects at a time.
Perform as the Subject Matter Expert (SME) on a variety of projects and range of technologies.
Training personnel on the weight and dispense operation on compliance requirement with training needs of department.
Assists Internal Audits has a primary point of contact.
Responsible for maintaining the schedule and successfully coordinating with Support Service Schedule/Planner Department.
Coordinate Cleaning with Central Services Department and/or support routine and non-routine cleaning.
Primary responsible person of maintaining a consistence compliance status of the weight and dispense area.
Required Skills & Abilities: Excellent oral and written communication skills, interpersonal and organizational skills.
Proficient with Microsoft Office applications.
Excellent leadership skills.
Ability to train others to perform to cGMP standards.
Good self-discipline and attention to detail.
Must be able to work flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary.
Must be able to work alternative shift hours and weekends as required.
Excellent math and computer skills.
Experience working in a cleanroom environment with full clean room gowning and good aseptic technique.
Must have good planning and time management skills and be willing and able to interface with colleagues in many different roles and functions throughout the manufacturing facilities.
Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
Ability to wear personal protective equipment including safety glasses, lab coat, safety shoes and gloves.
Ability to lift/push/pull up to 25 pounds frequently and up to 50 pounds occasionally.
Attendance is mandatory.
Manufacturing Weigh and Dispense Lead Minimum Qualifications: Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 2 years of relevant experience; OR Associate degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 4 years of relevant experience; OR High School/GED with 6 years of relevant experience.
Above experience must include two (2) years GMP experience.
Preferred Qualifications: Biotechnology certificate preferred.
Cross training with other identified functional areas.
Experience with buffers/media preparation, pH/conductivity adjustment and filter integrity testing.