Lead Associate, Manufacturing (Bulk Support) Night Shift

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Job description

Job Description

Job Purpose:

The incumbent will be a key shop floor leader in the manufacturing organization. The incumbent will independently provide the technical skill-sets and leadership necessary to manufacture high quality biologicals or sterile injectables safety in a compliant, efficient, and cost effective manner

• This position is on Night Shift
• Hours: 6AM-6PM
• Schedule: 2,2,3
• Candidates must be willing to work every other weekend

Major Accountabilities:

• Is an expert on processes and equipment and serves as a hands-on leader in Production
• Conducts all assigned activities in a safe and cGMP compliant manner. Tasks will include, but are not limited to:
• Cleaning, preparing, and sterilizing production equipment
• Cleaning and disinfecting production rooms
• Assembly, set-up, and disassembly of production equipment
• Executing process steps according to defined SOPs and BPRs
• Documenting activities and review of documentation in accordance with cGMPs
• Handling biologically and chemically hazardous goods
• Advanced understanding of process automation systems and advanced user of electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP, LiveLink)
• Leading projects of large scope (e.g. Operational Excellence, safety)
• Authoring SOPs and BPRs
• Coordinating Qualification and Validation activities
• Coaching and training other associates to become Qualified Trainers
• Coordinating equipment and personnel resources on daily basis
• Leading resolution to quality and process disruptions cross functionally
• Recognizing issues and effectively solving major atypical process issues
• Leads the collection and tracking of area metrics and process control data
• Leads complex investigator in root cause investigations and CAPA completion for deviations
• Leads a high performance teamwork environment and champions Seqirus Values and Behaviors
• Serves as team lead, may allocate work and provide subject matter guidance to more junior team members with problem solving and teamwork

Minimum Qualifications:

• High school diploma/GED or associate's degree with 7+ years' industry related experience (pharmaceutical, biotechnology, and/or sterile production environments) preferred OR bachelor's degree with 5+ years' industry related experience preferred OR equivalent
• Expert knowledge of cGMP requirements required
• Experience executing 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

About Us

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.

About 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 .

We want Seqirus to reflect the world around us

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

Do work that matters at Seqirus!