Purolite, an Ecolab Company, is looking for a Production Lead to join our team at our new Life Sciences manufacturing facility in King of Prussia, PA. This is a great opportunity to join and advance with an innovative and high-growth global company.

What You Will Do:

• Supervise assigned manufacturing operations which include: processing source materials, equipment and component preparation, inspection, and packaging.
• Report operational status to the next level of management, and with all affected peers on a daily basis.
• Review and update manufacturing documentation associated with the manufacturing areas.
• Provide cGMP, job task, and safety training for personnel in the manufacturing areas.
• Generation, update and maintain area Standard Operating Procedures (SOP) and BPR's. Compliance with cGMP through observation, training and auditing.
• Supervise hourly employee performance, including compliance with SOP's, cGMP's, and safety regulations.
• Perform deviation investigations related to assigned area of responsibility along with implementing corrective actions to prevent recurrence of such deviations.
• Order production supplies and equipment required to manufacture product.
• Interact with all supporting departments (ex: Quality Assurance, Maintenance, etc) to ensure production line problems are dealt with promptly and with appropriate quality considerations.
• Drive continuous improvement initiatives and recommend improvements to the Production Supervisor.
• Monitor and communicate non-conformances to the Production Supervisor or Senior managers.
• Work in a cleanroom environment.

Minimum Qualifications:

• High school diploma or equivalent,
• 5 years of experience working in pharmaceutical manufacturing production.
• 3 years of Lead/Supervisory experience.
• Working experience of cGMP Guidelines, FDA Regulations, cleanroom functions and etiquette with additional training provided as needed.
• Ability to effectively interact with all levels throughout the organization.
• Required to work shifts and weekends per business needs.

Preferred Qualifications:

• College or University degree.
• Strong analytical mindset with attention to detail, organization, prioritization, and time management.
• Clean room gowning experience, knowledge of vacuum transfer systems, fluid bed dryers, screening machines, AHU and/or milling techniques.
• Knowledge of chemical manufacturing and handling of fine powders.
• Experience grinding, homogenization, packaging of cGMP products, and handling API's.

Contacts and Relationships:

Interfaces with other department personnel in the QC Lab, administration, and management as necessary.

Maintains good relationship with maintenance to ensure preventive maintenances are completed on time as scheduled during down time.

Requires good communication, interpersonal skills and interacts well with external customers, visitors, employees, and management in other departments.

Will be the lead operator on the shift and have some supervisory duties.

Working Conditions:

Position operates mainly in a cGMP production environment. Most of the work will take place in a cleanroom which will entail cleanroom gowning. Product suites will sometime have excessive noise and vibrations, moving mechanical parts, potentials for electric shock, hazardous chemicals or fine powders, gases, odors, hot liquids, or equipment.

Physical Demands:

Physical requirements: Requires ability to sit and/or stand for extended periods of time, bend, reach, grasp, handle, push, pull, twist, kneel, squat, carry and lift uneven loads. Lift floor to waist, lift waist level and above, including overhead, up to and including 40 lbs. Climb step stools, stairs, and ladders.

Visual requirements: Requires ability to use tools, machinery, or lab equipment, including viewing computer screens, write and review documentation. Close visual acuity to perform mechanical or skilled tasks; fabricate or assemble parts or equipment. Ability to operate light equipment.

Close visual acuity to read small print, analyze data, transcribe, determine the accuracy, neatness or thoroughness of assigned work or work area.

Hearing requirements: Talk and/or hear normal audible sounds including the spoken word and sounds over the telephone. Understand and convey spoken instructions accurately, softly, loudly, or quickly, occasionally in a noisy environment.

Mental requirements: Ability to comprehend complex information or instructions, interpret and convey information in a written or oral format.

Emotional demands: Ability and willingness to deal with high stress fast paced situations and make accurate and quick decisions.