Specialist Manufacturing

Collabera; Thousand Oaks (CA); On-site; USD 48,000 - 52,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term disability insurance

Short-term disability insurance

Paid parking/public transportation

Paid time off

Paid sick and safe time

Paid vacation time

Paid parental leave

Paid holidays annually

Job summary

Collabera in Thousand Oaks, CA is seeking a manufacturing specialist focused on aseptic processing and drug product filling. The role supports 24/7 production, starting with M-F 8-5 and transitioning to Wed-Sun 8-5 when 24/7 operations begin in 2027.

Responsibilities include revising SOPs, owning aseptic deviations, driving continuous improvement, and turning floor data into actionable decisions. Candidates should have hands-on aseptic experience and be prepared for shift changes and

Qualifications

• Experience with aseptic practices and drug product filling.
• Experience in a 24/7 manufacturing environment is preferred.
• Experience revising controlled documents and records.
• Ability to own aseptic-related deviations.
• Develop metrics and actionable outputs from operational data.

Responsibilities

• Serve as a drug product aseptic processing technical resource for 24/7 manufacturing.
• Support continuous improvement initiatives to strengthen aseptic compliance and efficiency.
• Revise SOPs, work instructions, and related records to support changes.
• Own aseptic-related deviations and drive corrective actions.
• Support the 24/7 Ways of Working Lead by analyzing aseptic call data and trends.
• Develop clear metrics and outputs that translate data into decisions and priorities.
• Establish a cyclic process for gathering information, addressing challenges, and assessing effectiveness.

Skills

Aseptic processing

Drug product filling

Continuous improvement

Deviation management

SOP revision

Data analysis

Root cause analysis

Job description

• Candidates must have experience with aseptic practices and drug product filling. Suppliers must screen for this experience beyond familiarity
• Serve as a drug product aseptic processing technical resource supporting 24/7 drug product manufacturing. The role will begin with M-F 8-5pm, but transition to Wed-Sun 8-5pm once 24/7 operations commences in 2027.
• Support continuous improvement initiatives that strengthen aseptic compliance, process robustness, and operational efficiency.
• Revise controlled documents, including SOPs, work instructions, and related records, to support process changes and improvements.
• Own aseptic related deviations.
• Support the 24/7 Ways of Working Lead to evaluate 1+ year of aseptic call log data from the floor and identify recurring trends, root causes, and improvement opportunities.
• Develop clear metrics, summaries, and actionable outputs that convert operational data into decisions, priorities, and follow-up actions.
• Establish and maintain a cyclic process for gathering information, addressing challenges, implementing improvements, and assessing effectiveness.
• Candidates must have experience with aseptic practices and drug product filling. Suppliers must screen for this experience beyond familiarity
• Drug Product manufacturing experience
• Aseptic Compliance/Contamination Control Experience

Salary and Other Compensation:

The annual [salary/hourly rate] for this position is between$35.00 - $38.00 per hour.

The Company offers the following benefits for this position, subject to applicable eligibility requirements:

• [medical insurance]
• [dental insurance]
• [vision insurance]
• [401(k) retirement plan]
• [life insurance]
• [long-term disability insurance]
• [short-term disability insurance]

• [paid parking/public transportation]
• [Paid time off]
• [Days/hours of paid sick and safe time]
• [Days/hours of paid vacation time]
• [Weeks of paid parental leave]
• [Paid holidays annually]
• [any additional benefits applicable].