Catalent
pharma and biotech
ManufacturingSpecialistFill/Finish
“Manufacturing Specialist - Fill/Finish at Catalent. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, aseptic filling, GMP environment. Support the day-to-day operations of the manufacturing process. Provide oversight and guidance to tactical operations”
What You'll Achieve.
Support batch record review and disposition activities to meet lot release timelines
Industry & Context.
lean six sigma (LSS) problem solving; RCA / CAPA; quality remediations; process deviation investigations; investigations; troubleshooting
100% on-site
What They're Looking For.
Must Have
3+ years of aseptic filling experience in a GMP environment (Master's degree), 4+ years of aseptic filling experience in a GMP environment (Bachelor's degree), 5+ years of aseptic filling experience in a GMP-regulated manufacturing (Associate's degree/HS diploma), Knowledge of EU Annex 1, GMP’s, FDA regulations and documentation procedures required, Previous experience operating equipment such as: peristaltic or piston pump aseptic fillers, automated packaging lines, semi-automated visual inspection stations, autoclaves, parts washers, and filter integrity testers required, Previous experience in process deviation investigations and Previous experience authoring and/or revising technical documents required
Nice to Have
Experience as a MES, EMS, MRP, LIMS, or LMS user and basic programming skills a plus, Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget, Excellent communication and technical writing skills and can support and/or lead system troubleshooting efforts, Solid communication skills across technical and non-technical audiences and the ability to create and communicate complex concepts and analyses in easy-to-understand ways
What You'll Do.
Support the day-to-day operations of the manufacturing process
Provide oversight and guidance to tactical operations
Integrate continuous improvement and technical knowledge transfer
Act as the liaison between manufacturing and the site CI and MS&T organizations
Provide support for lean six sigma (LSS) problem solving
Provide support for value stream management
Provide support for continuous improvement assessment process
Provide support for electronic systems integration
Provide support for tech transfer
Provide support for manufacturing training
Provide support for RCA / CAPA
Provide support for quality remediations
Provide scheduling support and operational oversight for day‑to‑day fill/finish manufacturing activities
and report key performance parameters and in‑process controls
and QA teams to apply Lean Six Sigma and value‑stream management methodologies
Lead ongoing continuous improvement (CI) assessments within the fill/finish organization
Represent Manufacturing in defining user requirements and implementing electronic batch records (eBRs) and integrated systems
Provide technical leadership for fill/finish processes
Ensure product and process understanding to support high‑quality investigations and effective corrective actions
Develop and deliver on‑the‑job training for fill/finish associates
Support individual training plan management
Support batch record review and disposition activities to meet lot release timelines
Lead or support root cause author deviations
Contribute to quality remediation efforts
and present data for investigations
on‑the‑floor support for operational deviations
Performs other duties as assigned
How You'll Work.
Team & Collaboration
Cross-functional coordination; Partner with CI, MS&T, and QA teams; Represent Manufacturing in defining user requirements and implementing electronic batch records (eBRs) and integrated systems; Work effectively cross-functionally; Lead teams
Communication Scope
Excellent communication and technical writing skills; Solid communication skills across technical and non-technical audiences; Ability to create and communicate complex concepts and analyses in easy-to-understand ways
Process & Methodology
Implement project plans on time and on budget
Applying for this Manufacturing Specialist - Fill/Finish role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Catalent?
Real rants from real employees. Read before you apply.