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Changes To GMP Force Cleanroom Re-Classifications
2016-03-04 12:44:01| oilandgasonline Downloads
According to both USA cGMP and EU GMP cleanroom classification should be carried out according to ISO 14644-1. The 19994 version of this ISO standard has been re-written by a group of international subject matter experts and ISO 14644-1:2015 was published on December 15, 2015. ISO 14644-1:2015 contains substantial revisions impacting both the way the cleanrooms are classified and the performance requirements of the air particle counting instruments used to carry out the classification.
Assembly Operations Cleanroom Manager
2016-01-12 13:05:56| Space-careers.com Jobs RSS
Airbus Defence and Space is a division of Airbus Group formed by combining the business activities of Cassidian, Astrium and Airbus Military. The new division is Europes number one defence and space enterprise, the second largest space business worldwide and among the top ten global defence enterprises. It employs some 40,000 employees generating revenues of approximately 14 billion per year. A vacancy for an Assembly Operations Cleanroom Manager has arisen within Airbus Defence Space in Portsmouth. You will be dealing with changing priorities and daily challenges, this dynamic and essential role is vital to ensuring multiproject schedule adherence via the instigation of long term working plans for the operational team and infrastructure. You will manage of a team of up to 50 operators to ensure successful delivery of major satellite contracts in line with agreed schedules, to budget and on quality. You will define all aspects of assembly operations to achieve these goals including resource recruitment, capital investment, training plans, operations briefings and improvement of facilities for lean manufacturing. Your main tasks and responsibilities will include Daily personnel management right skill, right person, right place, right time succession planning, forward load, discipline, timekeeping, team morale, annual appraisals and recruitment. Validate the operational phase resource requirements and agree multi project manning levels to meet challenging schedules achieving high productivity on quality and on cost. Key stakeholder for analysis of forward load vs. capacity and succession planning for the cleanroom facility. Define training plan for operations team including input and signoff to training modules. Ensure the maintenance and improvement of the training facility. Manage and coordinate all assembly activities in the cleanroom, by deploying lean organisation enforcing company policies including 5S audits, Health and Safety, and specification of maintenance. Define and manage capital investment CAPEX for improvement and upkeep of the cleanroom, tooling and furniture. Interface with team leaders daily for project reporting, priorities, escalation, resource requirements, and variances. Oversee daily schedule adherence, management of assembly operational work packages and work package variance reporting to the internal customer AIT Project Manager. Responsible for assembly operator quality during operations and enforcing the use of AIT procedures and processes. Key customer for all engineering processes and encouraging team to think creatively and provide continuous feedback for improvement. Support and ensure attendance to lessons learnt sessions at project completion. We are looking for candidates with the following skills and experience Minimum of HNC level in a Mechanical Manufacturing discipline with extensive experience in Assembly or Production environment. Experience of Operations Management, Production Manufacturing Management. Proven Management or Team Leading experience. Previous Budget responsibility, experience in Cost and Resources Management. Good knowledge of Lean manufacturing techniques including 5S, Continuous Improvement. Experience with working in a high quality driven process orientated engineering organisation. Previous experience of telecoms payload builds would be desirable. Knowledge and understanding of clean room manufacturing. Knowledge of Health and Safety principles and their application to the specific environment would be desirable. Basic understanding of RF properties and associated risks would be desirable. Good Leadership and supervisory skills. Excellent interpersonal skills with the ability to work with teams from all levels of the business. High selfmotivation and ability to deal with changing priorities on a multi project basis. Please apply for this vacancy on line at our careers site www.jobs.airbusgroup.com with your CV attached. To apply click here
Tags: manager
operations
assembly
operations manager
Cleanroom Conveyor Oven cures low-friction coating onto vials.
2015-11-25 14:31:05| Industrial Newsroom - All News for Today
Electrically heated Gruenberg NFPA 86 Class A Conveyor Oven cures thin coating onto glass vials, used in pharmaceutical industry, to produce low-friction surface. This 4-module, 400°C oven, which contains 3 heating chambers and one chamber for cooling, processes 120 vials/min as they advance in trays along >30 ft conveyor belt. Installed in each chamber, 1,750 cfm, vertical-down, air-circulation system with HEPA filters ensures uniform heat distribution.
Tags: coating
oven
conveyor
cures
Bright Plastics Receives FDA Approval of Cleanroom Facility
2015-11-09 11:31:08| Industrial Newsroom - All News for Today
Greensboro, NC Bright Plastics, Inc. a custom injection molding company has received the Food and Drug Administrations (FDA) approval for its cleanroom operations. Bright Plastics maintains an ISO 8, Class 100,000 cleanroom in which various products are produced for the medical industry in a carefully...
Tags: approval
facility
bright
receives
Bee-Safe Cleanroom Apparel
2015-11-06 11:31:09| Industrial Newsroom - All News for Today
Enfield, CT High-Tech Conversions has expanded their line of Bee-Safe Cleanroom Apparel. The line now includes Polypropylene Bouffant Caps, Sterile Gloves, and Super Non-Skid Shoe Covers. Bee-Safe Polypropylene Bouffant Caps have a soft non-woven head cover and feature elastic edging for added strength and...
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