Fishers, Indiana, United States · On-site
$140k–$150k
The Senior Quality Process Validation Specialist provides QA oversight of Process Design (Stage 1), Process Performance Qualification (Stage 2), and Continued Process Verification (Stage 3) activities across the site. Th…
Skills: Process Validation, QA Oversight, PPQ Studies, CPV Programs, Risk Assessment
Fishers, Indiana, United States · On-site
Petco Veterinary Services offers relief veterinarians the chance to work in two distinct settings: Vetco Vaccination Clinics and Vetco Total Care full-service veterinary hospitals. In both environments, you'll have the o…
Skills: Veterinary Medicine, Vaccinations, Wellness Checks, Heartworm Testing, Microchip Placement
Fishers, Indiana, United States · On-site
Allisonville Meadows Assisted Living is now hiring QMAs for PRN (as needed) hours As a Qualified Medication Aide, you will have the opportunity to develop meaningful relationships by learning about the life stories of ou…
Skills: Medication Administration, Geriatric Nursing, Interpersonal Communication, Leadership, Collaboration
Fishers, Indiana, United States · On-site
About the Role This is a pivotal leadership role for a People Operations professional who wants to build something — not just maintain it. As Director, People Operations, you'll be the strategic and operational backbone …
Skills: People Strategy, Associate Relations, People Analytics, Employment Law, Multi-state Compliance
Fishers, Indiana, United States · On-site
$90k–$105k
Manufacturing Supervisor Summary: The Manufacturing Supervisor is responsible for overseeing production operations, ensuring that all work completed is within appropriate timeframes, delivering daily expectations and ass…
Skills: Production Oversight, cGMP Compliance, Aseptic Techniques, People Leadership, Process Control
Fishers, Indiana, United States · On-site
$20/hr–$42/hr
You’ve invested a lot of time and energy in your education. Now you want the chance to make your mark. We offer challenging opportunities for you to learn and grow professionally. In our programs, you’ll be immersed in a…
Skills: Prescription Fulfillment, Patient Counseling, Immunization Administration, Drug Utilization Review, Patient Safety
Fishers, Indiana, United States · On-site
SHIFT: PT Nights This position is referral eligible. **1 year of Labor & Delivery experience is required** Full time roles are eligible for a sign on bonus. The amount is dependent upon FTE - apply now to learn more! Are…
Skills: Labor & Delivery Nursing, OB Triage, Postpartum Care, OB OR Circulating, Patient Care
Fishers, Indiana, United States · On-site
SHIFT: Full-time Nights This position is referral eligible. **1 year of Labor & Delivery experience is required** Full time roles are eligible for a sign on bonus. The amount is dependent upon FTE - apply now to learn mo…
Skills: Labor And Delivery Nursing, OB Triage, Circulating In OB Procedures, Postpartum Care, Patient Care
Fishers, Indiana, United States · On-site
$80k–$99k/yr
Overview Are you a Physical Therapist looking to thrive in a supportive, balanced environment? Join ATI, a leader in Outpatient Physical Therapy, where you’ll be part of a team redefining musculoskeletal (MSK) care. With…
Skills: Patient Assessment, Treatment Planning, Musculoskeletal Care, Outpatient Physical Therapy, Patient-Centered Care
Fishers, Indiana, United States · On-site
$17/hr–$20/hr
Job DetailsJob Location: 89-00-Fishers - Fishers, IN 46037Salary Range: $17.00 - $20.00 HourlyJob Title: Patient Service Representative Reports To: Practice Manager Join a team that cares for your community – and for you…
Skills: Patient Registration, Appointment Scheduling, Payment Collection, Insurance Verification, Medical Billing
Fishers, Indiana, United States · On-site
$40/hr–$45/hr
The Manufacturing Engineering Technician is a key technical role within INCOG BioPharma Engineering and Technical Operations to ensure data integrity, implement state-of-the-art digital technologies, process control stra…
Skills: Aseptic Filling, GMP Manufacturing, Process Design, Data Integrity, Electro-mechanical Systems
Fishers, Indiana, United States · On-site
$85k–$115k/yr
Dental Hygienist Sign On Bonus: $10,000 Job ID: 553 Average Salary: $85,000-$115,000 per year (based on experience, days worked, and additional compensation) Location: 10438 Olio Rd, Fishers, IN 46040 Job Type: Full Time…
Skills: Patient Care, Dental Hygiene, Clinical Collaboration, Patient Education, State-of-the-art Equipment
Fishers, Indiana, United States · On-site
$85k–$95k
TSMS – Senior Technical Transfer Engineer The Technical Services and Manufacturing Sciences (TSMS) Senior Technical Transfer Engineer will be responsible for supporting all facets of Tech transfer, Process Validation, GM…
Skills: Technical Transfer, Process Validation, cGMP, Scale-up, Root Cause Analysis
Fishers, Indiana, United States · On-site
$100k–$125k
Working closely with the QA Batch Manager, the Senior QA Batch Specialist will be instrumental in supporting major QA programs related to batch review, disposition and continuous improvement. They will also be key in cha…
Skills: Batch Disposition, Aseptic Processing, GMP Compliance, Quality Management Systems, Deviation Investigation
Fishers, Indiana, United States · On-site
$110k–$130k
TSMS - Process Validation Engineer The Technical Services and Manufacturing Sciences (TSMS) Process Validation Engineer will be responsible for supporting all facets of Process Validation, GMP Floor Support, and Continue…
Skills: Process Validation, cGMP, Process Performance Qualification, Technical Writing, Root Cause Analysis
Fishers, Indiana, United States · On-site
$110k–$130k
TSMS – Senior Process Validation Engineer The Senior Process Validation Engineer - Technical Services and Manufacturing Sciences (TSMS) will be responsible for leading all facets of Process Validation, GMP Floor Support,…
Skills: Process Validation, cGMP, Process Performance Qualification, Continued Process Verification, Root Cause Analysis
Fishers, Indiana, United States · On-site
$25/hr–$30/hr
The QC Microbiology Technician will work closely with QC Microbiologists and the QC Microbiology Manager to support development and readiness activities for the Quality Control Microbiology lab. The QC Microbiology Techn…
Skills: Microbiology Techniques, Environmental Monitoring, Sampling, GMP Compliance, Laboratory Documentation
Fishers, Indiana, United States · On-site
Manufacturing Specialist Summary INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. …
Skills: Sterile Pharmaceutical Manufacturing, Industrial Automation, GMP Manufacturing, Aseptic Processing, Equipment Troubleshooting
Fishers, Indiana, United States · On-site
$130k–$165k
This position will serve as INCOG’s leader for managing and executing the site security program at INCOG Biopharma, a contract development and manufacturing organization (CDMO). This role ensures the safety and security …
Skills: Physical Security Management, Access Control, CCTV, GMP Compliance, Incident Investigation
Fishers, Indiana, United States · On-site
Job DetailsJob Location: Fishers YMCA - Fishers, IN 46038Position Type: Part TimeJob Category: Health and WellnessBenefits Include: Free YMCA of Greater Indianapolis Membership 20 Hours Per Week of Free Child Care Flexib…
Skills: Exercise Science, Wellness Principles, Strength and Conditioning, Relationship Building, Empathy
Fishers, Indiana, United States • On-site
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Provide QA oversight for the three stages of the process validation lifecycle for aseptically filled drug products. Responsible for approving validation protocols, risk assessments, and ensuring compliance with FDA, EMA, and ICH regulatory requirements.
Requires a Bachelor's degree in science or engineering and at least 5 years of experience in pharmaceutical or CDMO manufacturing. Must have hands-on experience with PPQ studies, CPP/CQA identification, and a deep understanding of aseptic processing validation.
The Senior Quality Process Validation Specialist provides QA oversight of Process Design (Stage 1), Process Performance Qualification (Stage 2), and Continued Process Verification (Stage 3) activities across the site. This role is responsible for ensuring validation protocols, risk assessments, PPQ studies, and CPV programs meet applicable regulatory expectations and internal procedures, while taking direct, hands-on ownership of protocol design, execution, lifecycle documentation, and ongoing process monitoring.
Provide QA oversight and approval of process validation activities of aseptically filled drug product across all three stages of the process validation life cycle, including Process Design, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).
Review and approve process validation life cycle documents including risk assessments, process flow diagrams, critical process parameter (CPP) and critical quality attribute (CQA) identification, validation protocols, and summary reports.
Ensure all process validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs.
Oversee process-related change controls to ensure appropriate revalidation assessments are performed, documented, and closed in a timely manner.
Participate in the development, review, and revision of process validation-related SOPs, policies, and guidance documents.
Serve as a QA subject matter expert during internal and external audits and regulatory inspections related to process validation activities.
Support deviation investigations and CAPA activities related to process validation, PPQ, and continued process verification; review and approve deviations associated with process validation
Maintain current knowledge of regulatory trends, guidance documents, and industry best practices related to process validation, including FDA’s 2011 Process Validation Guidance, EU Annex 15, and ICH Q8-Q12.
Bachelor’s degree in a science or engineering field (e.g., Chemistry, Biology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline).
Minimum of 5 years of experience in pharmaceutical, biopharmaceutical, or CDMO manufacturing with direct involvement in process validation activities.
Demonstrated hands-on experience in designing and executing process validation protocols, including Process Performance Qualification (PPQ) studies, for aseptically filled drug product.
Working knowledge of the three-stage process validation life cycle as defined in the FDA 2011 Process Validation Guidance, including Process Design, Process Performance Qualification, and Continued Process Verification.
Direct experience with critical process parameter (CPP) and critical quality attribute (CQA) identification, statistical process monitoring, and process capability analysis. Familiarity with NOR/PAR determination, and other process design and qualification using ICH Q8 methodology.
Thorough understanding of FDA, EMA, and ICH regulatory requirements and guidance documents applicable to process validation (e.g., FDA Process Validation Guidance, EU Annex 15, ICH guidances; PDA and ISPE Process Validation and Technology Transfer guidances).
Familiarity with technology transfer activities and the associated process validation requirements for new product introductions.
Experience in a sterile injectable or aseptic manufacturing environment, particularly within a CDMO setting.
Experience with aseptic processing validation, including media fills, hold time studies, shipping validation, and container closure integrity testing.
Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to process validation activities.
Working knowledge of statistical tools and software used for process capability analysis, control charting, and continued process verification trending (e.g., Minitab, JMP).
Experience authoring or reviewing Annual Product Quality Reviews (APQRs) or Product Quality Reviews (PQRs) as part of continued process verification programs.
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
By submitting your resume and details, you are declaring that the information is correct and accurate.
A CDMO with an unparalleled customer-centric approach.
Our services support injectable drug products, including technical transfer, analytical method development and validation, process scale up, and formulation & filling of vials, syringes and cartridges. In addition, we offer customized packaging services to include labeling, device assembly, auto injector assembly, cartoning, final packaging and integrated storage solutions at various temperature conditions.
Offices: Fishers , Indiana, US
There are currently 243 open healthcare positions in Fishers, IN listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include INCOG BioPharma Services, Ascension, Indiana University Health, American Senior Communities, Community Health Network, among others. Browse the listings above to see every active employer.
Yes — 24 of the 243 open healthcare positions offer remote or hybrid work (10 remote, 14 hybrid).
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