Commissioning and Qualification and Validation Engineer - Berekeley, CA | Biospace
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Commissioning and Qualification and Validation Engineer

ICQ Consultants Corp

Location:
Berekeley, CA
Posted Date:
7/28/2017
Position Type:
Full time
Job Code:
01745
Salary:
Required Education:
Other
Areas of Expertise Desired:
Automation, Biomedical, Biomedical Engineer, Biotechnology, Consultant, Engineering, General Services, HPLC, Laboratory, Manufacturing, Medical Device, Other, Pharmaceutical, Process Development, Process Engineer, Professional Services, Project, Project Management, Project Manager, QA, QC, Quality, Quality Assurance, Quality Control, Technical Services, Validation,

Job Description

ICQ Consultants is currently looking for candidates with general commissioning, qualification and validation experience as well as computer system validation (CSV) engineers with one to fifteen years of expierience.  We are looking for candidate’s local to the Berkeley, CA and San Francisco Bay area as well as the general Boston, MA area.  Only candidate’s local to these areas should apply.  The position has responsibilities for all aspects of planning, coordination, development, execution and close out of commissioning, qualification and/or validation protocols/reports meeting quality and schedule expectations.  ICQ Integrated Commissioning & Qualification Corporation serves the pharm/biotech and Medical Device community by providing skilled engineering personnel and leading edge technical expertise in a wide range of disciplines. The success of our business is grounded in the long-term success of our clients, not one-time engagements. We recognize that good business for us, as well as for our clients depends on building lasting, trusted relationships. Whichever service we are called upon to provide, we strive to become an extension of our client’s organizations, developing programs and procedures that promote, facilitate and ensure compliance with regulatory guidelines, while also aligning with our clients own internal quality standards. ICQ Consultants has an ongoing commitment to our employee’s professional development through training and mentoring programs. In this way, we can assure our clients that every one of our team members is well-trained and well-qualified for a wide variety of consultant engagements.

Requirements

All positions require a solid foundational understanding working in FDA-regulated industries within one or more of the following areas of commissioning, qualification and/or Validation: Process Validation,  
Sterilization Processes,  
Packaging Line Processes,  
Cleaning Processes,  
Facilities, Utilities and Process Equipment,  
Depyrogenation Processes,  
Analytical Lab Processes,  
Automation/Computer Systems (Delta V, PLCs),  
Project Management,  
Cycle Development,  
Shake down, Start-up and Turn Over Activities,  
Decommissioning Activities and / or
Environmental Monitoring.  General requirements for working with ICQ are
Working knowledge of FDA and ICH requirements:  
21CFR Parts 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packaging or Holding of Drugs General.  
21CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals.  
21CFR Part 11, Electronic Records and Electronic Signatures.  
ICH Q7, GMP Guide for Active Pharmaceutical Ingredients.  
Working knowledge of Quality by Design (QbD) principles and approach:
ICH-Q9, Quality Risk Management,  
ICH-Q10, Pharmaceutical Quality System,  
ASTM E2476, Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture,  
ASTM E2500, Standard Guide for Specifications, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.  
Demonstrated ability to meet quality and schedule expectations related to the planning, coordination, development, execution and close out of commissioning, qualification and/or validation protocols/reports.  
Demonstrated ability to customarily and regularly exercises discretionary powers and sound independent judgment.  
Demonstrated ability to work independently or as an effective team member, leader, of project manager while completing all assign work.  
Demonstrated ability to clearly and effectively communicate with project team members, management, clients.  
Demonstrated ability to take ownership in obtaining, interpreting and understanding client and vendor-supplied documentation in order to meet assignment deliverables and expectations.  
Participate in internal ICQ Consultants and industry required training to ensure continued accreditation.  
Complete all other tasks within quality and schedule expectations as assigned.  
Travel may be required.  
Employee must always be compliant with the company’s Standard Operating Procedures (SOPs) and policies.  
Strong attention to detail,  
Proficient in MS Word and MS Excel,  
Ability to handle many tasks with limited direction and
Ability to deliver results is a must.  
Demonstrated interest in continued professional development, provide a high level of customer support, be a representative of the company,  
Desire to help others, be in industry leader and the belief that every problem has a solution.  Educational Requirements include a
BS/BA degree in a Scientific/Engineering Discipline or 1 to 15 years’ related experience working in FDA-regulated industries within one of the following areas:
Manufacturing,  
Engineering,  
Process Development,  
Quality Assurance (QA),  
Quality Control (QC),  
Commissioning, Qualification and/or Validation and / or  
Computer System Validation.