杭州招聘

Summary
The validation Manager position effectively and efficiently manages all validation for equipment, facility and System and IT system for Geneception (Hangzhou), to provide overall validation support that are in accordance with Company requirements and governing agencies that are well documented. Apply extensive industry experience to troubleshoot and optimize facility equipment and all utilities. Work independently to identify and initiate projects for facility improvements.

Responsibilities:
1) Draft procedure and report of facility/equipment/instrument qualification.
2) Perform the execution of facility/equipment/instrument qualification.
3) Coordinate with Facility Department in terms of validation instrument calibration.
4) Responsible for validation/qualification annual review, requalification, deviation, change control, investigation, CAPA, and/or the other GMP activities related to facility, equipment, and cleaning. Able to write change controls, deviations and CAPAs in a logical and clear manner and follow up progress.
5) Support in process/analytical method/cleaning validation coordinating with other related department/team.
6) Prepare monthly/weekly summary report for facility/equipment/instrument qualification related activities.
7) To communicate with and assist different group or department in a timely manner to fulfill the work assignment with efficiency.
8) Conduct the work assignments in compliance with cGMP regulations whenever applicable.
9) Finish the other tasks assigned by the supervisor
Requirement:
Education:
? BS degree in chemical, mechanical, electrical engineering or equivalent experience
Experience:
? Minimum 5 years’ experience in engineering/engineering management, preferably in a pharmaceutical/FDA-regulated work environment.


Skillsets:
1) High level of attention to detail.
2) Excellent documentation skills.
3) Knowledge of facility engineering/design such as HVAC system, clean facility is a plus.
4) Knowledge and experience in cGMP/FDA regulations. Experience in regulatory audits desired.
5) Excellent verbal, written and interpersonal communication skills.
6) Demonstrated ability to manage and lead personnel.
7) Demonstrated ability to handle multiple complex tasks and make timely/appropriate decisions with respect to product quality, compliance and the customers.
8) Strong math (statistical), root cause analysis and troubleshooting skills.
9) A full complement of business computer literacy skills (e.g. word processing, spreadsheets, database software etc.)
10) Demonstrated experience in handling and responding to customer complaints and inquiries.
11) Demonstrated ability to read, write and speak clear English.

Physical Requirements:
1) Ability to stand for up to 8 hours per day
2) May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others.
3) Frequent sitting, standing, walking, climbing ladders/steps, reading of written documents and use of computer monitor screen, reaching with hands and arms, stooping, kneeling, crouching, talking, bending, grasping, listening.
4) Occasional, walking up inclines and uneven terrain, writing, carrying.
5) Frequent lifting and/or moving up to 50 pounds.


Note to External Recruiters:

All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that:

1, Recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation.

2,Without prior authorization with an official contract, Recruiters not to contact potential candidates using Geneception’s company name, logo, position information, our leadership team members’ names, etc; any un-authorized efforts of approaching candidates with Geneception’s company information will not create an implied obligation, and Geneception will trace the recruiters’ activities of spreading any authorized or misleading information among the candidates, appropriate legal actions will be taken by Geneception when necessary;

赋源生物是一家创新驱动的生物制药公司，致力于基因和细胞治疗的药物开发，以及在全球范围内的临床研发及商业化。

赋源生物总部位于上海，自2019年成立以来，公司已经打造行业一流的研发和管理团队，并在上海张江落成6000平米的自主研发中心，成为国内基因与细胞研发领域的研发中心。公司将以此为起点，积极推进自主研发与对外合作研发项目，尽快满足病患临床需求。

公司已经完成1.5亿美金A轮融资，由高瓴资本、红杉资本和ARCH Venture Partners领投，创始投资机构斯道资本、F-Prime Capital和礼来亚洲基金跟投。