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 · Hybrid
$40k–$60k/yr
Benefits: Bonus based on performance Health insurance Paid time off Training & development 401(k) matching Company parties Competitive salary Dental insurance Opportunity for advancement Vision insurance Overview Priorit…
Skills: Prospecting, B2B Sales, Relationship Development, Risk Identification, Pipeline Management
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
Applied Innovation is seeking a results-driven and highly motivated Account Manager to join our Sales team. This role is responsible for developing new business opportunities, maintaining strong client relationships, and…
Skills: Prospecting, Negotiation, Closing, Customer Service, Interpersonal Communication
Fishers, Indiana, United States · On-site
$40k–$60k/yr
Overview Discover an exciting new career opportunity at Roto-Rooter as a Water Restoration Technician. Founded in 1935, Roto-Rooter is North America's largest plumbing, drain cleaning, and water cleanup services provider…
Skills: Water Extraction, Carpet Cleaning, Construction, Lawn Care, Pest Control
Fishers, Indiana, United States · On-site
$13/hr–$13/hr
Job DetailsJob Location: Fishers, IN 46038Position Type: SeasonalSalary Range: $13.25 - $13.25 HourlyJob Category: AquaticsBenefits Include Free YMCA of Greater Indianapolis Membership 20 Hours Per Week of Free Child Car…
Skills: Lifeguarding, CPR, First Aid, Emergency Response, Pool Safety
Fishers, Indiana, United States · On-site
$13/hr–$13/hr
Job DetailsJob Location: Fishers YMCA - Fishers, IN 46038Position Type: SeasonalSalary Range: $13.25 - $13.25 HourlyJob Category: AquaticsBenefits Include Free YMCA of Greater Indianapolis Membership 20 Hours Per Week of…
Skills: Lifeguarding, CPR, First Aid, Emergency Response, Pool Safety
Fishers, Indiana, United States · On-site
IS IT TIME FOR A CAREER CHANGE? INDEPENDENT INSURANCE CLAIMS ADJUSTERS NEEDED NOW! Are you ready to embark on a dynamic and in-demand career as an Independent Insurance Claims Adjuster? This is your chance to join a thri…
Skills: Claims Adjusting, Insurance Licensing, Disaster Recovery, Field Inspection
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
Job DetailsJob Location: 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 Flexible Hours/Schedu…
Skills: Exercise Science, Wellness Principles, Strength and Conditioning, Relationship Building, Empathy
Fishers, Indiana, United States · On-site
$14/hr–$20/hr
Benefits: 401(k) 401(k) matching Bonus based on performance Competitive salary Dental insurance Employee discounts Flexible schedule Health insurance Paid time off Training & development Vision insurance Live your best l…
Skills: Personal Care, Mobility Assistance, Transferring Patients, Range Of Motion Exercises, Meal Planning
Fishers, Indiana, United States · On-site
$14/hr–$20/hr
Benefits: 401(k) 401(k) matching Bonus based on performance Competitive salary Dental insurance Employee discounts Flexible schedule Health insurance Paid time off Training & development Vision insurance Live your best l…
Skills: Personal Care, Mobility Assistance, Transferring Patients, Range Of Motion Exercises, Meal Planning
Fishers, Indiana, United States · On-site
$14/hr–$20/hr
Benefits: 401(k) 401(k) matching Bonus based on performance Competitive salary Dental insurance Employee discounts Flexible schedule Health insurance Paid time off Training & development Vision insurance Live your best l…
Skills: Personal Care, Mobility Assistance, Transfers, Range Of Motion Exercises, Meal Planning
Fishers, Indiana, United States · On-site
CDL-A DRIVER NEEDED FOR A DEDICATED HOME *DAILY ACCOUNT! MINIMUM 1 YEAR RECENT TRACTOR TRAILER EXPERIENCE! MUST HAVE AT LEAST ONE SEASON OF WINTER DRIVING EXPERIENCE AVERAGE WEEKLY: $1950.00 - $101,400 YEARLY PALLET JACK…
Skills: CDL-A, Tractor Trailer Driving, Winter Driving, Pallet Jack Operation, Freight Delivery
Fishers, Indiana, United States · On-site
Job DetailsJob Location: Conner Prairie Museum - Fishers, IN 46038Position Type: SeasonalTravel Percentage: NoneJob Shift: AnyJob Category: Restaurant - Food ServicePrincipal Function: The Concessions Staff is responsibl…
Skills: Food Preparation, Cash Handling, Customer Service, Food Safety, Sanitation Standards
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Lead all facets of process validation, GMP floor support, and continued process verification for clinical and commercial programs. Provide technical leadership in executing process performance qualifications and mentoring junior engineering staff.
Requires a Bachelor's degree in Science or Engineering with 3-5 years of GMP experience and 2+ years in process validation. Must possess strong knowledge of CMC regulatory requirements and experience with aseptic filling or device assembly.
The Senior Process Validation Engineer - Technical Services and Manufacturing Sciences (TSMS) will be responsible for leading all facets of Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. This role will provide advanced technical leadership to ensure robust and reliable production processes are established and maintained across multiple programs.
This position will lead the delivery of technical guidance and assistance throughout the process validation of production processes. The primary objective is to independently execute Process Performance Qualifications and Continued Process Validation activities while mentoring junior staff.
- Lead TSMS Process Validation activities by providing advanced technical guidance to operations and technical transfer project teams on Process Performance Qualification with minimal supervision
- Independently create complex process qualification documentation such as Process Validation Master Plans, Protocols, Summary Reports, and related validation documents for multiple product lines
- Serve as technical lead in project teams and manage customer communications. Recognized as Subject Matter Expert for multiple manufacturing processes
- Author and review complex GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms across multiple programs
- Monitor and analyze Process Data across multiple manufacturing areas, identify trends and implement corrective actions independently
- Lead technical troubleshooting and investigations of complex process issues to support comprehensive root cause analysis, product impact assessment and effective corrective and preventive actions
- Lead cross-functional teams in assessing and implementing new technology for GMP manufacturing with strategic impact
- Provide advanced technical guidance to team members in technical matters of process validation and mentor Entry Level engineers
- Conduct comprehensive impact assessments of changes to the product, process, equipment, procedures and/or materials across multiple programs
- Demonstrate strong understanding of CMC regulatory requirements specifically with respect to process validation and support regulatory submissions
- Effectively engage and collaborate with both internal and external team members across cross-functional groups and lead client interactions
- Lead identification of continuous improvement opportunities and drive implementation of those improvements with measurable impact
- Stay current with trends and practices in the industry to support best in class processes and share knowledge with team members
- Other responsibilities as required
- Bachelor's degree in Science or Engineering required
- Master's degree in Science or Engineering preferred
- 3-5 years of GMP experience required
- 2+ years of experience in process validation principles for formulation, aseptic filling and/or combination product (device assembly) processes
- Strong understanding of CMC regulatory requirements and process validation methodologies
- Advanced analytical and problem-solving skills with demonstrated leadership capabilities
- Excellent communication skills and proven ability to lead cross-functional teams and manage client relationships
- Advanced proficiency in Microsoft Office applications, statistical analysis software, and data analysis tools
- Demonstrated ability to work independently in a fast-paced, regulated manufacturing environment
- Experience with regulatory submissions (preferred) and client-facing technical presentations
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
