• United States Of America, Usa

Job Description:

This position reports to the Associate Director of Engineering Technical Services supporting both GMP clinical manufacturing and non-GMP development scale-up manufacturing This position will be an engineering role with individual contributor responsibilities Responsible for maintaining reliable equipment performance for multiple manufacturing systems at AstraZenecas Gaithersburg Scale-up and Clinical Manufacturing facilities including cell culture, purification, and support systems A senior engineer would also be responsible for tracking metrics and facilitating shutdowns, and may supervise one or more FTEs (depending on experience, qualifications, and group needs)

Subject Matter Expert (SME) on two or more Biotech manufacturing processes and equipment
Resolves daily operational issues for one or more assigned manufacturing areas
Performs troubleshooting, maintenance, and process performance optimization
Manages projects, and coordinates shutdowns and return to service activities
Writes, tracks, and executes SAP work orders
Creates and revises Preventative Maintenance plans
Coordinates maintenance activities with Facilities
Coordinates service contracts and work of outside vendors Leads cross functional teams and contractors
Obtains quotes and purchases parts and equipment, and adds spare parts to the SAP inventory system
Monitors equipment performance Identifies equipment issues and develops technical solutions
Determines process requirements Helps design, install, and commission new processes and equipment
Writes cGMP documentation (SOPs, protocols, etc)
Writes other documentation including user requirements, specifications, validation test-scripts, HECPs, drawings, and reports
Performs quality/safety investigations and risk evaluations Owns and executes Quality and Safety CAPAs
Performs complex GMP change control activities Senior Engineers may approve equipment validation and change control documents
Instructs staff on process systems and operation Supports ETS training and the ETS apprentice program Mentors more junior staff
Develops new engineering projects Creates project scopes, URS, and timelines
Represents Manufacturing and Engineering Services on equipment projects managed by other engineering groups
Reviews specifications, work instructions, protocols, drawings, and reports for technical accuracy
Evaluates new equipment technologies Participates in tech transfers if needed
Provides on-call support and works overtime as needed

EDUCATION (minimum requirements)
Bachelors degree in Engineering (Chemical Engineering preferred), Computer Science or Life Sciences (Other candidates with extra experience may be considered)

EXPERIENCE (minimum requirements)
Senior Engineer 8-years engineering experience including 6-years of GMP experience in a biotech or sterile pharmaceutical manufacturing environment 4-years of project management experience, change management, and investigation experience required Experience with budgeting, presentations to upper management, and/or compliance audits a plus

Engineer II 4-years engineering experience including 3-years of GMP experience in a biotech or sterile pharmaceutical manufacturing environment Experience with project management, change management, and investigations a plus

GMP change management experience and project management experience
Previous expertise with operating and/or maintaining either upstream biotech manufacturing equipment (including bioreactors/fermenters, CIP skids, and centrifuges) or downstream biotech manufacturing equipment (including chromatography skids and columns, TFF filtration, tanks, and CIP skids)
Good oral and written communication skill, and good interpersonal skills

Good at trouble shooting and problem solving
Hands on mechanical, electrical and/or electronic skills
Expertise in the design, operation, and maintenance of chromatography equipment a plus
Previous experience managing facility shutdowns a plus
Familiarity with Cleanroom design and utility systems a plus
Previous experience with sterile filling and/or Lyo a plus
Experience with automated process control systems (PLC / SCADA)

Senior Engineer
Works under minimal supervision
Assigns tasks to others; receives no instructions on routine work and minimal instruction on new assignments
Interacts regularly with functional level peers, junior functional area staff, and all levels of management

Engineer II
Works with some supervision
Initiates routine tasks; normally receives no instructions on routine work and general instructions on new assignments
Interacts regularly with functional level peers, junior staff, and cross-functional management

Next Steps Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity If you know someone who would be a great fit, please share this posting with them

AstraZeneca is an equal opportunity employer AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law

Engineer II / Senior Engineer - BPD


Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 20th Feb 2020

Key Skills:

Company Profile:


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