湖州招聘

I. Basic Function:

(A brief statement describing the basic purpose of the job.)

Responsible for managing engineering/EHS programs. This includes new equipment, utilities and systems selection, fabrication, installation and commissioning, and any upgrades to existing ones. To comply with all relevant cGMP, EHS and company requirements and policies while executing job.

II. Specific Activities, and Responsibilities:

(A concise list of the key responsibilities of the job.)

Organization

· Manages and facilitates the functional requirements, design qualification, and design specification process.

· Manages and facilitates new and upgraded equipment, utilities and systems.

· Manages and facilitates the implementation and execution of cGMP requirements as they relate to equipment, utilities and systems.

· Manages and facilitates the drawings for all site equipment, utilities and systems.

Team Development

· Ensures staffing of the department is appropriate for assigned projects.

· Ensures that staff is appropriately trained in the cGMP’s and company policies and procedures related to their responsibilities.

· Sets goals and objectives for the department and monitors progress against those objectives.

· Interviews candidates, evaluates and counsels staff as appropriate, in conjunction with Human Resource requirements.

· Recommends, evaluates and manages external contractors.

Analysis and Information Management

· Interfaces with Technical Services, QC, Manufacturing, Validation, and QA to understand, document and present technical engineering information.

Program Delivery

· Reviews and approves functional requirement, design specifications, design qualification.

· Reviews and approves commissioning plans.

· Reviews and approves policies and procedures for the department.

· Prepares project plans for engineering projects.

· Prepares status reports to advise management of the engineering status for the facility.

· Lead teams to achievement improve the facilities performance to meet customer needs.

· Maintains program documentation in an organized and secure fashion.

Customer Focus

· Interfaces with customers on engineering requirements for the equipment, utilities and systems used to manufacture their product.

· Interfaces with customers to resolve technical issues arising from the execution of engineering protocols.

· Develops responses to customers’ audit observations.

Compliance

· Ensures that engineering/EHS protocols and reports are prepared to meet the current cGMP’s and industry standards.

· Interfaces with FDA on engineering-related topics during inspections.

· Manages and minimize all deviations, CAPAs, Trackwise, QIR and QA Holds relating to Engineering.

· Stays current, and provide training for staff to stay current with the regulatory requirements and industry trends for engineering.

III. Knowledge Requirements:

Education or Equivalent: (Minimum required to perform job.)

· BS or advance degree in Engineering (Mechanical, Electrical, Chemical, or Civil), or Chemistry, Biology, Pharmacy, or related physical sciences.

· At least 10 years of engineering-related experience in pharmaceutical operations.

· Solid knowledge of the engineering principles and concepts with respect to facilities, equipment, utilities and systems.

· Sound EHS knowledge and experiences

· Thorough knowledge of the cGMP regulations and CADD.

· At least 5 years of management experience with demonstrated ability to problem solving, working as a key member of a management team, and motivating/guiding staff to meet company objectives.

Knowledge/Skills Requirements: (Unique knowledge skills, or problem-solving requirements.)

· PC skills, including training on Catalent’s software packages.

· Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures and financial reports.

· Ability to write reports, business correspondence, and standard operating procedures.

· Ability to effectively present information and respond to questions from groups of managers, customers, and regulatory agencies.

· Good command of English in writing and speaking

About Catalent

Catalent Pharma Solutions is a leading Drug Development, Advanced Delivery Technology and Supply partner to the global pharmaceutical industry. A Fortune 1000 company, with over 20 locations on 5 continents, we partner with 90 out of the top 100 pharmaceutical companies and 44 of the top 50 biotech firms, as well as thousands of small innovator companies.

About Catalent Pharma Solutions
Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. With over 75 years of experience, we have the deepest expertise, the broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance and provide superior, reliable manufacturing and packaging results.

Catalent develops. With our broad range of expert services we drive faster, more efficient development timelines to help you take more molecules to market and create more effective products.

Catalent delivers. As the world leader in drug delivery innovations, we have a proven record of enhancing bioavailability, solubility and permeability, improving ease and route of administration, and increasing patient compliance for better treatments.

Catalent supplies. Globally positioned to serve all your manufacturing and commercial packaging needs, we provide integrated solutions to take your product from design, to clinical trial, to plant, and to pharmacy.

Catalent. More products. Better treatments. Reliably supplied.

More information please refer to: www.catalent.com

Catalent (康泰伦特）于2012年进入中国，浙江康泰伦特江元堂生物科技有限公司是美国康泰伦特（Catalent) 和浙江江元堂合资的一家中外合资企业，主要产品为保健食品，公司已经通过保健食品GMP认证，澳洲TGA认证、出口食品生产企业卫生注册、ISO9001、HACCP认证审核，产品远销欧州、美国、东南亚等国家和地区。公司以人为本，重视员工的培养和发展，期待各方人才加盟。

公司地址：浙江省海宁市长安镇城南路399号