EWH Technician Lead

This is what you will do:

The Egg White Harvest Lead Technician will perform all daily EWH activities including harvests, environmental monitoring, sampling, line clearances, and documentation; follow standard operating procedures and good documentation practices; organize, clean, and maintain harvest suite, supplies, and equipment. The Lead EWH Technician will support the production facility by working shifts, weekends, and holidays as needed.

You will be responsible for:

• Maintain inventory levels and order raw materials as needed.
• Generate and maintain daily / weekly schedules of activity and ensure task completion.
• Serve as Qualified Trainer (QT) for critical EWH tasks.
• Actively engage with leadership and Protein Production Unit (PPU) personnel to ensure schedule adherence is maintained.
• Leads team in absence of Manager.
• Performs initial review of completed Master Batch Records (MBRs)
• Performs initial entry and review of deviations and supports change control activities.
• Plans and prepares shipments of EW to downstream processing facilities.
• Proposes and implements changes to documentation for improved clarity and process improvements.
• Supports special projects as needed, including maintaining ownership of key management systems, such as 5S and training.
• Egg white harvest according to established Standard Operational Procedures (SOP’s) in accordance with current Good Manufacturing Practices (cGMP).
• Execution of MBRs in accordance with Good Documentation Practices (GDP).
• Aseptic manipulations within a laminar flow room according to established Standard Operating Procedures (SOP’s).
• Equipment operation (EM and manufacturing)
• Accountability to individual and team safety policies and procedures.
• Completion of cGMP documentation according to approved procedures
• Process sampling
• Ability to withstand -20C temperature exposure with appropriate Personal Protective Equipment (PPE)
• Cleaning and sanitization of equipment
• General housekeeping of manufacturing area
• Maintains EWH and EM databases

You will need to have:

• High School Diploma plus 8 years’ experience in cleanroom or GMP environment or
• BS, AS, or Certificate plus 5 years’ experience in cleanroom or GMP environment
• Must be able to work within and adapt to complex electronic systems such as SAP and Trackwise
• Must be able to read, write and converse in English
• Proficiency in Outlook, Word and Excel and knowledge of PC spreadsheets required.
• Ability to work in an intense, fast-paced work environment.
• Ability to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously
• Ability to work independently and as part of a team
• 5-8 years’ experience in a cGMP biopharmaceutical manufacturing environment
• Excellent verbal and written communication skills.
• The duties of this role are generally conducted in a pharmaceutical manufacturing environment. As is typical of a pharmaceutical manufacturing-based role, employees must be able, with or without an accommodation to: frequently lift/carry 15/30 pounds unassisted/assisted; stand for prolonged periods of time; walk and move for prolonged periods of time; climb stairs or ladders; gown/degown PPE and uniforms; use a computer with a keyboard and mouse; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• cGMP, biopharmaceutical experience preferred
• Experience with inventory control methods and electronic inventory systems preferred.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.