Quality Engineer III (Pharma Manufacturing)

Actalent • Saint Louis, MO • 1h ago

Job Title: Quality Engineer IIIJob Description

The Quality Engineer III is a seasoned quality assurance professional with extensive experience in a quality or manufacturing setting within a highly regulated industry. This role focuses on evaluating and improving production processes to enhance quality and efficiency. The engineer will work closely with manufacturing teams to ensure compliance with industry standards and regulations, thereby supporting the production and release of high-quality bulk drug substances for clinical and commercial clients.

Responsibilities

Oversee activities and provide QA-related input to support manufacturing.

Collaborate with cross-functional teams to develop and optimize processes for better efficiency and quality.

Conduct thorough audits and inspections to maintain compliance with industry standards and regulations.

Observe aseptic practices and provide immediate coaching to prevent contamination.

Participate in client and regulatory audits as a subject matter expert on procedures and practices.

Monitor critical process steps to ensure adherence to procedures and batch records.

Conduct daily GEMBA walks in active manufacturing areas and provide immediate feedback.

Approve suite and equipment changeovers between client processes.

Review autoclave logbooks and facilitate necessary corrections.

Perform monthly aseptic observations and provide training and mentorship to team members.

Write and review deviations, CAPAs, and procedures using Trackwise and eDMS systems.

Essential Skills

Extensive quality assurance experience in GMP/FDA pharmaceutical QA.

On-floor QA oversight over manufacturing processes.

Experience in CAPAs, SOPs, and batch record reviews.

Ability to conduct root cause analysis and make independent decisions.

Additional Skills & Qualifications

Bachelor's Degree in Life Sciences (biology, chemistry, biochemistry) or related field with a minimum of 5 years of relevant experience.

Non-science degrees considered with 7 years of biopharmaceutical manufacturing experience.

Cleanroom manufacturing experience preferred.

Familiarity with Trackwise and root cause analysis tools.

Technical writing skills and experience in document management software.

Experience in Lean Manufacturing and Six Sigma methodologies is a plus.

Work Environment

The role involves working 80% of the time on the manufacturing floor gowned in blues or whites (bunny suit) and 20% at a desk. The working hours are 6:00am-4:30pm, with rotating 10-hour shifts following a 2-2-3 schedule. Employees must comply with cleanroom gowning requirements and be able to lift a minimum of 25 lbs independently. The position requires standing for 80% of the shift.

Job Type & Location

This is a Contract to Hire position based out of Saint Louis, MO.

Pay and Benefits

The pay range for this position is $42.00 - $48.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Saint Louis,MO.

Application Deadline

This position is anticipated to close on Mar 31, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

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