Job Information
Actalent In-Process Quality Engineer (1st Shift) in Raleigh, North Carolina
Job Title: In-Process Quality Engineer (1st shift)Job Description
We are seeking a dedicated In-Process Quality Engineer to provide on-floor quality oversight across cGMP manufacturing operations, including formulation, filling, sterilization, packaging, and warehouse activities. This role focuses on ensuring compliance with site SOPs and cGMPs during production and warehouse operations, supporting QA inspections, and maintaining high standards of quality assurance.
Responsibilities
Provide primary daily support to the production and warehouse area, including tasks such as packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real-time review.
Respond to exceptions within operations/packaging areas as primary QA event response personnel, conducting initial exception impact assessment, product containment, bracketing, initial scope identification, and directing immediate actions prior to resuming processing.
Assist personnel in generating operations/packaging area related exceptions and support minor exceptions and phase II manufacturing investigations.
Attend daily operations staff communication meetings and participate as a team member in Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling.
Assist in punch list generation and verification, as well as area inspections pre/post activity, perform weekly walkthroughs of the operations/packaging area, and communicate observations to associated area management.
Support batch release functions as needed, accurately completing all documentation including batch records, logbooks, and deviation reports in compliance with cGMP and data integrity requirements.
Promptly report and assist in investigating any contamination events or deviations from aseptic practices.
Essential Skills
Thorough understanding of cGMP and applicable regulatory guidelines (FDA, EMA, etc.) for aseptic processing.
Hands-on experience providing QA oversight on the manufacturing floor, including formulation, filling, sterilization, packaging, or warehouse GMP operations.
Experience performing or verifying line clearances, room clearances, and/or batch record review.
Familiarity with deviation management, root cause analysis, and execution of corrective and preventative actions (CAPA).
Skilled competency with computers and MS Office software.
Ability to pass a visual acuity exam for production and identification of quality product purposes.
Excellent reading comprehension and attention to detail for interpreting batch records and SOPs.
Additional Skills & Qualifications
Bachelor's degree in Life Sciences, Engineering, or a related technical discipline (e.g., Biology, Chemistry, Microbiology, Pharmaceutical Sciences).
3-6 years of experience in pharmaceutical manufacturing, quality assurance, or aseptic operations.
Experience observing and evaluating aseptic behaviors, gowning qualification, environmental controls, and contamination control practices preferred.
ASQ inspection certification preferred.
Experience working with ISO, FDA, or EU Annex-1 regulated environments preferred.
Experience with pharmaceutical CAPA systems (e.g., Trackwise, Metric Stream, etc.) preferred.
Basic understanding of sterilization processes, material flows, and controlled environment requirements.
Work Environment
This position operates within a controlled production environment located in a pharmaceutical manufacturing facility. The role requires flexibility to support off-shifts or weekend operations as needed based on production schedules. The ability to stand for extended periods while performing on-floor manufacturing oversight is necessary, along with the capability to lift a minimum of 50 lbs. Candidates must be physically able to wear full clean room gowning and Personal Protective Equipment (PPE).
Job Type & Location
This is a Contract to Hire position based out of Raleigh, NC.
Pay and Benefits
The pay range for this position is $33.00 - $37.00/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 Raleigh,NC.
Application Deadline
This position is anticipated to close on Apr 28, 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.