Lead Associate (Fill Finish) Day Shift

Job Purpose:

Reporting to the Director of Fill Finish, you will be an important shop floor leader in our manufacturing organization. You will independently provide the technical skill-sets and leadership necessary to manufacture high quality biologicals and sterile injectables with us. You will ensure these actions are completed safety in a compliant, efficient, and cost-effective manner

Day Shift.

Hours: 6AM-6PM

Schedule: 2,2,3

You must be willing to work every other weekend

You Will:

• Be an expert on processes and equipment.
• You will be the hands-on leader in Production for the team.
• Assign activities across the team.
• Clean, prepare, and sterilize production equipment.
• Clean and disinfect production rooms.
• Assembly, set-up, and disassembly of production equipment
• Accomplish process steps according to defined SOPs and BPRs for us.
• Document activities and review of documentation following cGMPs
• Handle biologically and chemically hazardous goods with us.
• Work with automation systems and advanced user of electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP, LiveLink)
• Lead projects of large scope (e.g. Operational Excellence, safety)
• Author SOPs and BPRs
• Coordinate Qualification and Validation activities
• Train other team members to become Qualified Trainers
• Coordinate equipment and personnel resources on daily basis
• Resolve quality and process issues and work to correct.
• Recognize issues and solving major atypical process issues
• Lead the collection and tracking of area metrics and process control data
• Lead complex investigations and CAPA completion for deviations
• Evoke Seqirus Values and Behaviors

• High school diploma/GED or associate's degree with 7+ years' industry related experience (pharmaceutical, biotechnology, and/or sterile production environments) OR bachelor's degree with 5+ years' industry related experience preferred OR equivalent
• Experience of cGMP requirements required
• Experience completing SOPs and documenting work required
• Advanced mechanical aptitude or knowledge of electronic / mechanical equipment
• Expert in clean room environment practices with demonstrated ability to train others
• Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO on your first day of hire

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.