SkillSet: Disposable mixing technology, stainless steel technology.
The individual will play a critical role in the qualification/validation of equipment routine operation, and change management with Support Operations of the Biologics pilot plant whose purpose is to produce material for toxicology, phase I and phase II clinical trials to support clinical development pipeline.
Specifically, this person will contribute to the success of the operation by providing technical expertise for equipment and processes that support manufacture of materials for global clinical supplies.
The individual will also be responsible to maintain and/or enhance the production area processes supporting media/buffer manufacturing, raw material and component planning, procurement, and to remain compliant to regulations.
Education: BS in Biological/Chemical/Physical sciences, or Engineering is a must Experience: Minimum of 3-5 yrs in a multi-discipline cGMP environment, commissioning and operating equipment in Support production areas.
Minimum of 1-2 yrs experience in SAP at a pharmaceutical or bio-technology company preferred.
Proficient in the operation of all area specific production equipment such as washer, autoclave, and disposable mixing technology for media and buffer solutions.
Must be willing to work any shift in supporting 24/7 bulk operations that may include weekends, holidays and overtime, as required.
Must be able to sit and/or stand for extended periods of time and be able to lift 25 lbs.
Self-starter with a strong focus on detail, safety, quality and results.
Ability to multi-task and adjust to varying priorities to meet timelines.
Ability to identify, investigate, and trouble-shoot basic process and equipment problems.
Working knowledge of cGMP, EMEA, and JP regulations.
Good written and communication skills.
Good problem solving and interpersonal skills with the ability to work in a team environment required.
MUST HAVES: Knowledge of GMP guidelines Experience with media and buffer preparation Disposable mixing technology or stainless steel technology SAP experience Pilot Plant experience preferred Autoclave washEducation
: ("Graduation in any field")Skills
: Disposable mixing technology or stainless steel technologyFunctional Area
: R&D / Product DesignCompany Type
: Pharma / BiotechMin Salary
: INR Rs 2.0 Lakh / YrExperience
: 2 Yrs