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Specialist Manufacturing-31625

BioPharma Consulting JAD Group
Juncos, PR
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

BioPharma Consulting JAD Group has a great Specialist Manufacturing with an industry leader working on site in Juncos, Puerto Rico. This is a temporary position for 8 months with the possibility of extension.

Job Summary:

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

FUNCTIONS

Applied Process Expertise

  1. Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
  2. Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities
  3. Provide troubleshooting support.
  4. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.

Process Monitoring

  1. Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations
  2. Provide support of timely execution of the process monitoring quarterly reports

Non-Conformance and CAPA

  1. Ensure that all Non-conformances are triaged within the established goal.
  2. Responsible for authoring investigation reports
  3. Responsible for execution of corrective actions.
  4. Responsible for managing NC/CAPA closure within established goal
  5. Monitor and communicate incidents trends.
  6. Review equipment/system Root Cause Analysis investigations and support trend evaluations

Process Validation

  1. Assist with generation of process validation protocols and reports
  2. Assist with the execution of the process validation
  3. Support collection and analysis of process validation data

Regulatory

  1. May participate in regulatory inspections

New Product Introductions & Process or Equipment Modifications

  1. Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
  2. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

Change Control

  1. Assist manufacturing change owner on CCRB packages impacting the process.

Projects and Initiatives

  1. Participate on the assessment or implementation of special projects or initiatives.
** Other functions may be assigned

Education:

Doctorate degree

OR

Master's degree and 3 years of Manufacturing Operations experience

OR

Bachelor's degree and 5 years of Manufacturing Operations experience

OR

Associates degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience.

Preferred Skills:

  • Detailed technical understanding of bioprocessing unit operations
  • Skilled in performance of GMP production operations
  • Regulatory knowledge and interactions
  • Participate and help lead cross functional team
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
  • Organizational, technical writing and presentation skills.- Basic project management skills
  • Basic knowledge of control charting
  • Educational background in Chemistry or Biochemistry
  • Thorough knowledge in the use and application of Pharmacopeias (USP, EP and JP)
  • Thorough knowledge of pH, Conductivity, Osmolality, Absorbance, Protein Concentration, Appearance, Color, Clarity, and Endotoxin test for biological products and preparation of surface sampling kits for Total or Non Purgeable Organic Carbon (TOC or NPOC) analysis
  • Experience with chemistry laboratory equipment: ( ie: UV- spectrophotometer Osmometer, Turbidimeter, etc)
  • Knowledge in Laboratory Sample Flow
  • Knowledge in Analytical Methods Transfer to the Manufacturing and Quality Control Facilities
  • Experience and Knowledge in Analytical Method Monitoring and Invalid Tracking and product data Monitoring
  • Experience in Analytical Investigations and Handling of Out of Specification and Unexpected Results
  • Knowledge in Computerized Systems Data Integrity Assessment and Security Assessment.
  • Knowledge in electronic laboratory documentation [Electronic batch record (EBR), CIMS and/or Laboratory Management electronic system (LMES)]
  • Thorough knowledge of CFRs, GMPs and pharmaceutical processing and demonstrated ability to apply
  • Detailed technical understanding of bioprocessing unit operations
  • Skilled in performance of GMP production operations
  • Regulatory knowledge and interactions
  • Participate and help lead cross-functional teams
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
  • Organizational, technical writing and presentation skills
  • Basic project management skills
  • Basic knowledge of control charting

Requirements

Our client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, the company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to the company, its operations, or its staff.

BioPharma Consulting JAD Group

Address

Juncos, PR
USA

Industry

Manufacturing

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