Lead Associate, Manufacturing

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With the state-of-the-art manufacturing facility and an expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

Reporting to the Supervisor, you will be onsite working in our Holly Springs facility as a Lead Associate within manufacturing operations. You will provide (train in) the technical skill-sets necessary to manufacture high quality biologicals safely in a compliant, efficient, and cost-effective manner.

Responsibilities:

· 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)

· 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

· Be point of contact and mange team when Supervisor is out.

· 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

Shift: Day/Night

· Hours: 6PM – 6AM

· Follow 2-2-3 schedule

Qualifications:

· 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