Job Summary:
Responsible for manufacture of biologics products performing activities within production facilities to support manufacture of upstream/ downstream operations according to current Good Manufacturing Practices (cGMPs).
Essential Duties and Responsibilities:
Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics Policies and Standard Operating Procedures. Able to coach and mentor others to do the same
Identifies, communicates, addresses, and improves simple cGMP compliance and regulatory gaps and issues; and participates/implements continuous improvement ideas
Participates, provides information in the development of and authors basic technical documents such as non-conforming events and deviations
Operates, maintains, and troubleshoots equipment
Participates on and performs technical transfer, validation and other facility start up activities
Uses all support systems (e.g. LIMS) with demonstrated proficiency and able to act as an subject matter expert (SME) on a system
Collects, records, reviews, performs analysis, interprets, identifies trends of scientific and process data per good document practices
Follows, executes, authors, and improves the efficiency and execution of Standard Operating Procedures (SOPs) and Batch Records (BRs)
Trains others on SOPs, equipment, and all unit operations
Identifies, participates, and suggests solutions to technical problems
Participates, supports, and assists as an SME during regulatory inspections and client audits
Performs well under direct supervision and works independently on basic tasks and processes
May be required to work Holidays/ weekends, overtime & work outside normal business hours
Contributes to the overall operations and to the achievement of departmental goals
Other duties as assigned
Qualifications:
HS Diploma required and AS/BS/BA in Science related field preferred.
Minimum 2-3 years relevant manufacturing experience
Understands aseptic technique concepts
Line Manager MFG Supervisor or Higher
Understands most operations and functions of equipment and is able to perform minor troubleshooting
Possesses basic technical knowledge and background in the pharmaceutical and biotechnology industry
Possesses basic and fundamental facility start-up experience
Understands the concept of and has performed or experience with manufacturing processes and methods
Possess basic computer skills and able to efficiently use basic Microsoft applications
Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
Physical Requirements:
Must be able to work in Lab setting with Biohazards /various Chemicals
Must be able to wear appropriate PPE
Must be able to work in environment with variable noise levels
Ability to stand /Sit/walk for long periods of time
Clarity of Vision
Ability to identify and distinguish colors
Must be able to perform activities with repetitive motions
Ability to climb Ladders / Stairs / Scaffolding
Ability to work in variable temperatures high to freezing
The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
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