Manager- Validation Center

Entegris, Inc. (Hangzhou, 中国) 2天前发布

Why work at Entegris?
Lead. Inspire. Innovate. Define Your Future.
Not everyone who works for a global company shares the same background, experiences and perspectives. We leverage the differences of our employees to bring new ideas to the table. Every employee throughout the company is encouraged to share input on projects and initiatives. Our decision making process is truly a collaborative effort as we realize there are leaders at every level of the organization. We put our values at the core of how we operate as an organization — not just when it’s convenient, but in a lasting and meaningful way. We want the time and energy you spend here to have a positive impact on your life inside and outside of the office.

Entegris is a values-driven culture and our employees rally around our core PACE values:
People

Accountability

Creativity
Excellence

ANOW need to find a experienced manager to take charge of validation group/lab and regulation compliance affairs . He/she will report to general manager and keep close cooperation with sales, BD, quality, PD and R&D dept to insure all the external and internal project go smoothly.

  • Managing lab group and project group of validation center , providing leadership and technical guidance;
  • Leading the LS products validation projects under standard conditions and customer specified conditions, and prepare corresponding validation guidelines;
  • Leading the software and hardware construction of the validation labor in the new factory, including laboratory design & decoration, special test system setup and so on.
  • Leading the lab CNAS (ISO17025) project and finishing the related document;
  • Leading the test and validation of biochemical projects of new materials;
  • Leading installation, training, and maintenance of validation lab equipment and consumables;
  • Responsible for the validation knowledge training of all departments within the company;
  • Leading the validation of special process in production process;
  • Participating in the writing and revision of internal product standards and specifications.
  • Leading the pharm and medical industry regulation projects related to the filtration industry. Keeping continuous communication with CFDA;

Keeping smooth communication with standard associations, and leading the establishment process of national and industry standards;

Responsible for technical cooperation project with universities and special system certification (such as water sanitation license) and specific product inspection (Third-part lab);

  • Cooperating with the BD dept. in exhibition, business visit, target customer training and technical service, and also cooperate with BD dept. in writing external validation technical documents, product documents and bidding documents, etc.
  • Possessing an attitude of ownership, responsibility, and never willing to quit;
  • Technical ability competency;
  • Building trusting relationships with internal and external companions;
  • Good Communication ability;
  • 7+ years of experience in QC, R & D department and third-party drug testing analysis or R&D testing laboratories of filtration, medical, pharmaceutical or pharmaceutical packaging materials companies, and must have 5+years of experience related the management of chemical and microbial lab group;
  • Familiar with the theory and knowledge of LS filtration industry;
  • Familiar with pharmaceutical and medical regulation and standard of different countries; such as PDA, BPOG,BPSA,USP,EP,JP,CP,MDR,510K and DMF;
  • Loving lab and regulation work, can use excel or origin to process test data;
  • Good English and Mandarin speaking, writing and reading skills.
  • Completing internal and external service projects by department, and constantly update their knowledge and skills.
  • To be results oriented;
  • Ability to build strong relationships with all companions within Entegris;
  • Strong self-motivated character and excellent problem-solving skills;
  • Good interpersonal skills, self-starter, ability to work independently and global communication skill.

Our total rewards package goes above and beyond just a paycheck. Whether you’re looking to build your career, improve your health, or protect your wealth, we offer generous benefits to help you achieve your goals.

  • Very Competitive total compensation plans.
  • A 401(K) plan to help you plan for your future with an impressive employer match that’s all yours- no vesting!
  • Great health, dental and vision insurance packages to fit your needs to ensure you’re happy and healthy.
  • A progressive PTO policy that empowers our employees to take the time they need to recharge!

At Entegris we are committed to providing equal opportunity to all employees and applicants. Our policy is to recruit, hire, train, and reward employees for their individual abilities, achievements and experience without regard to race, color, religion, sexual orientation, age, national origin, disability, marital or military status.

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Manager- Validation Center

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