Manufacturing Process Specialist

2 weeks ago

Indianapolis, Indiana, United States PDS Tech Commercial Full time
Job Overview

Are you an expert in process optimization with a strong ability to transform intricate challenges into efficient solutions? We are seeking a Manufacturing Process Specialist to enhance our pharmaceutical operations and refine our production methodologies. If you possess a drive for innovation, a commitment to regulatory compliance, and a passion for improving lives, this opportunity is for you.

Position Title: Manufacturing Process Specialist
Employment Type: Full-time; Consultant (6-month contract)
Location: Indianapolis, IN
Work Schedule: Monday to Thursday; First Shift
Compensation: $30.00 to $40.00 per hour

As a Manufacturing Process Specialist, you will deliver essential support to the production team, ensuring that each batch is produced safely and adheres to established protocols and quality standards. You will serve as the Subject Matter Expert (SME) for both product and process knowledge, acting as the primary resource for addressing product and process-related inquiries. You will lead investigations to identify root causes and implement corrective and preventive measures.

Key Responsibilities:

  • Oversee and maintain manufacturing documentation, including Master Batch Records, relevant Standard Operating Procedures (SOPs), risk assessments, and other necessary documentation.
  • Engage in technical writing and review to support manufacturing operations, including but not limited to SOPs, batch records, and technical papers.
  • Gather data for ongoing process verification (OPV), assist in monitoring and evaluating product performance, and facilitate the implementation of Corrective and Preventive Actions (CAPAs).
  • Lead investigations related to material transfer, API synthesis, Drug Substance formulation, drug product filling, inspection, and packaging.

Qualifications:

  • Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent experience.
  • A minimum of 3 years of experience in a process support role within GMP manufacturing and/or Quality Assurance/Quality Control.
  • Demonstrated understanding of pharmaceutical processes, GMP, and regulatory requirements.

Compensation Details: $30.00 to $40.00 per hour

We offer a comprehensive benefits package for our associates, which may include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, Employee Assistance Programs (EAP), commuter benefits, and a 401(k) plan. Our benefits allow employees to select coverage that best meets their individual needs. Additionally, associates may qualify for paid leave, including Sick Leave and other paid leave as mandated by law, along with applicable holiday pay.

We are an Equal Opportunity Employer/Veterans/Disabled.

Company Overview: Since 1977, PDS Tech Commercial has become one of the largest and most respected staffing firms in the United States. As a vital part of the PDS family, we connect highly skilled professionals with the needs of Fortune 500 clients for project support, including contingent labor, statement of work/offload engineering projects, and permanent placements.

PDS Tech Commercial collaborates with leading organizations across the United States and globally, hiring job seekers daily for various skill categories, including Engineering, IT, Business Professional, Administrative, Accounting/Finance, Skilled Trades, and Industrial.

We provide eligible associates with a flexible benefits package, which may include direct deposit, free career counseling, 401(k), select paid holidays, short-term disability insurance, skills training, employee referral bonuses, and affordable medical coverage.

As part of The Adecco Group, our collaboration enhances the advantages we offer to both clients and associates. We are committed to unlocking our Associates' potential while promoting human and labor rights, diversity and inclusion, and environmental responsibility.

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