Production Supervisor 3rd Shift

$55-65K

Our manufacturing client is looking to hire a Production Supervisor to their 3rd shift in the Waterloo, IA area. This Supervisor will plan, organize and supervise the activities of the assigned manufacturing department to ensure production and quality metrics are met.

Key Responsibilities:

• Provide direction to associates daily, ensuring the production schedule and requirements are clearly communicated and updated as necessary.
• Help solve production issues and make corrections as needed.
• Carry out supervisory responsibilities to include training employees; appraising performance; issuing corrective actions and recognitions.
• Help ensure scrap and waste is minimized and cost meets budget requirements.
• Conduct safety communications as needed.
• Maintain good housekeeping practices, 5S, ensure operator PM’s of equipment are performed.

Job Qualifications:

• High School Diploma or GED required.
• 3+ years of experience in a manufacturing environment.
• Experience with lean manufacturing or continuous improvement techniques is highly desirable.
• Excellent communication skills-able to train others.

Additional Incentives:

• Comprehensive Health Benefits Package
• 401K
• Vacation and Paid Time Off

Process Engineer

$60 – $75K

Our Manufacturing Company  Client is searching for a Process Engineer in the Clear Lake, IA area. This Engineer will identify and deliver service improvement activity across the business through employing process improvement methodologies and the application of innovative thinking.

Key Responsibilities:

• Work with key business stakeholders, and multi-jurisdictional LEAN champions, to build a continuous improvement environment to support an ongoing program of change.
• Lead and facilitate LEAN/process improvement-based workshops to drive ideas and solutions.
• Identify trends and process variations as part of establishing a continuous improvement monitoring system.
• Recommend methods for improving utilization of personnel, material and utilities.
• Recommend modifications to existing quality or production standards to achieve optimum quality within limits of equipment capability.
• Create and maintain products in ERP system, including materials, time, routing, coefficients and cost.

Job Qualifications:

• Bachelor’s Degree in Engineering.
• 3+ years of experience with Continuous Improvement and helping to drive engineering principles and process improvement.
• Lean Manufacturing experience.
• Experience with Process Improvement Methodologies and innovative thinking.
• ERP experience.
• Experience with time studies and motion studies.

Additional Incentives:

• Comprehensive Health Benefits Package
• 401k

Vacation and Paid Time Off

Validation Engineer – Medical Devices

My Client is looking for a remote Validation Engineer who can provide process validation support for new and legacy product manufacturing. This includes investigating deviations, nonconformance reports, and validation compliance reviews.

The best person for this role will use his or her experience in an ISO/FDA cGMP environment to validate diagnostic medical device manufacture.

Qualifications – Must Have:

BS, or equivalent, and 1-3 years of experience.

Experience with validation in an FDA regulated cGMP environment.

Proven experience with diagnostic or medical devices.

Proven experience with validation processes and documentation.

Manufacturing Engineers, Upstream (Pharmaceutical)

My Client is looking for experienced Manufacturing Engineers to support our viral vector production. We are looking for both an upstream Engineer and a downstream Engineer with biologics experience.

The Upstream Engineer will be responsible for designing and implementing production processes, equipment, and appropriate systems. He/She will have experience with bioreactor systems; scale-up; and appropriate cleaning, nutrition, and harvest procedures.

This engineer will use his/her aseptic experience to optimize culture growth, yield, and quality. He/she will validate systems and ensure quality, as well as train and mentor junior personnel.

Qualifications:

BS/MS in Science and 4+ years of related experience.

Proven cell culture and bioreactor experience. (Biologics is a must-have)

cGMP experience is a must

Excellent communication and organization skills

Prior six-sigma/lean processes are a plus

Manufacturing Engineer, Downstream and Upstream (Pharmaceutical)

My Client is looking for experienced Manufacturing Engineers to support our viral vector production. We are looking for both an upstream Engineer and a downstream Engineer with biologics experience.

The Downstream Engineer will be responsible for designing and implementing harvest processes, equipment, and appropriate systems. He/She will have experience with bioreactor systems; yield-optimization; and appropriate cleaning, chromatography, and filtration procedures.

This engineer will use his/her aseptic experience to optimize compliance, yield, and quality. He/she will validate systems and ensure quality, as well as train and mentor junior personnel.

Qualifications:

BS/MS in Science and 4+ years of related experience.

Proven downstream cell culture and bioreactor experience. (Biologics is a must-have)

cGMP experience is a must

Excellent communication and organization skills

Prior six-sigma/lean processes are a plus

Manufacturing Supervisor – Pharmaceutical Biologics

My Client is looking for a Manufacturing Supervisor to assist with the purification and recovery of pharmaceutical biologics. The right person for this role will have extensive cGMP experience in an FDA-regulated pharmaceutical environment. He or she will be familiar with developing processes, batch records, SOPs, BHR/BPRs, etc. This person will also be involved with the non-conformance and deviation reporting (CAPAs, Incident Reports, Deviation reports, RCA, audits, etc.)

The right person for this role will coordinate manufacturing to optimize performance, safety, yield, cost, and equipment usage. He or she will also play a key role in ensuring company and departmental goals are met. Filtration/Chromatography and other downstream techniques are key for this role.

Qualifications:

BS in Science, engineering, or similar and 4+ years of experience

Proven experience with biologics (cell-manufacturing) using CHO cells

3+ years retrieval, purification, and recovery (chromatography, filtration, etc.)

Proven experience writing SOPs and reports

Excellent communication skills

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