Specialist Manufacturing - Drug Development

Creative Solutions Services, LLC; Thousand Oaks (CA); On-site; USD 48,000 - 54,000; Part time

Benefits offered by this job

Medical, Vision, and Dental

401k Retirement Plan

Job summary

Creative Solutions Services, LLC seeks a Specialist Manufacturing specialist to support aseptic drug product manufacturing in Thousand Oaks, CA. The role emphasizes data review, compliance, and media fill protocol development for a 24/7 facility.

The position requires hands-on experience in sterile/aseptic environments, strong CAPA and documentation skills, and a track record of continuous improvement. Onsite role with a 12-month contract and shift changes as operations move to 24/7 in 2027.

Qualifications

• Experience in drug product manufacturing, preferably sterile/aseptic.
• Strong knowledge of aseptic processing and contamination prevention.
• Excellent written and verbal communication skills.

Responsibilities

• Support continuous improvement initiatives for aseptic compliance and operation efficiency.
• Revise and control documents (SOPs, work instructions) to reflect changes.
• Own aseptic-related deviations and CAPA reviews.
• Analyze 24/7 operation data to identify risks and improvement opportunities.
• Prepare media fill protocols, including scope, batch size, and acceptance criteria.
• Provide on-the-floor support during aseptic operations.
• Collaborate with the 24/7 readiness team to ensure readiness.

Skills

Drug product manufacturing

Aseptic compliance

Communication skills

Education

Doctorate or higher

Job description

Specialist Manufacturing - Drug Development

Location: Thousand Oaks, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 12 months
• Pay Rate: $35.00–$39.00 / Hour (USD)
• Shift / Schedule: Role will begin with Monday–Friday, 8:00 AM–5:00 PM, then transition to Wednesday–Sunday, 8:00 AM–5:00 PM once 24/7 operations commences in 2027.
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

This role supports a drug product manufacturing facility operating in an aseptic environment, with a focus on data review, compliance, and media fill protocol development. The position serves as an aseptic processing technical resource supporting 24/7 drug product manufacturing, and will support continuous improvement initiatives that strengthen aseptic compliance, process robustness, and operational efficiency.

Key Responsibilities

• 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.
• Analyze production data to identify bottlenecks and risks for 24/7 operations in 2027.
• Write reports and perform compliance reviews related to aseptic manufacturing.
• Collaborate with the 24/7 operational readiness team.
• Prepare media fill protocols, including scope, batch size, interventions, acceptance criteria, and incubation conditions.
• Provide on-the-floor support during aseptic operations.
• Develop metrics, actionable outputs, and manage completion of those outputs.

Required Skills

• Drug product manufacturing experience
• Aseptic compliance / contamination control knowledge
• Outstanding communication skills

Preferred Skills

• Prior involvement in 24/7 operational readiness or continuous manufacturing operations
• Familiarity with regulatory expectations for aseptic processing (FDA/EMA) and GMP documentation practices

Education Requirements

• Doctorate degree; OR Master's degree and 2 years of experience; OR Bachelor's degree and 4 years of experience; OR Associate's degree and 8 years of experience; OR High school diploma / GED and 10 years of experience

Required Experience

• Project management within drug production/manufacturing (sterile or aseptic environment strongly preferred)
• Hands-on experience with media fill / aseptic process simulation activities
• Demonstrated experience in CAPA reviews (corrective and preventive actions) or similar quality/compliance investigations

Nice-to-Have Experience

• Prior involvement in 24/7 operational readiness or continuous manufacturing operations

Work Environment / Physical Requirements

• Fully onsite role supporting drug product manufacturing operations
• Role begins on a Monday–Friday schedule (8:00 AM–5:00 PM) and transitions to a Wednesday–Sunday schedule (8:00 AM–5:00 PM) when 24/7 operations commence in April 2027

Important Notes

• Interview process: Initial phone screen with recruiter, followed by virtual interviews with the hiring team.

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-13558 Industry: Manufacturing & Operations

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