Initiate, propose and implement optimization projects to reduce quality incidents, manufacturing costs, cycle times and/or increase product yield. Develop project justification and capital project proposal when required. You will work with Production, Maintenance and QA to ensure existing manufacturing processes remain in control. Develop process monitoring metrics to maintain cGMP compliance of manufacturing processes.
Manage complex projects using a designed project model to develop necessary milestones and deliver success including adherence to required time, quality and budget restrictions
Apply engineering and process innovations to reduce ergonomic stress to operators.
Develop and update process specifications for new processes and equipment. Manage transfer of manufacturing processes from other sites to Irvine.
Develop required SOPs for new processes and equipment. Revise SOPs for existing processes as needed. Manage change control for processes as required.
Coordinate transfer of process and equipment information with Validation.
Lead process trouble shooting efforts and corrective action implementation. Assist Maintenance department in specific trouble shooting of process equipment and controls.
Generate data that supports investigations for both internal and external customers.
Write protocols and report results of studies conducted, prepare literature for Marketing publication when applicable
Who you are:
Degree in Mechanical, Electrical, Automation or Chemical Engineering with related experience or equivalent combination of education and experience.
Significant cGMP manufacturing experience in the biotechnology or pharmaceutical industry including Project management experience and including the management of project budgets, scope and schedules.
Extensive hands-on experience with process equipment.
Extensive component selection and Process control systems/software experience.
Experience of processing plant design/commissioning/validation.
Proven ability to lead and participate as part of a team.
Extensive knowledge of Facility utilities such as WFI, CCA, HVAC, pure steam systems, and Nitrogen
Sound knowledge of structured project management methodologies – preferably with formal project management accreditation.
Effective communication, influencing and decision-making skills at all levels
Excellent and proven team building and team motivational skills
Strong organising and time management skills with the ability to prioritize tasks.
Job Requisition ID: 201119
Career Level: D - Professional (4-9 years)
Working time model: full-time
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.