Fishers, Indiana, United States · On-site
$75k–$95k
We are looking for an Engineering Technical Writer who is a detail-oriented documentation professional with a strong technical background and a thorough understanding of GMP documentation standards in a regulated pharmac…
Skills: Technical Writing, Root Cause Analysis, GMP Compliance, Deviation Writing, Ishikawa Fishbone
Fishers, Indiana, United States · On-site
$100k–$120k
The Production Engineer 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 strategies, and suppo…
Skills: Aseptic Filling, Sterile Manufacturing, GMP Manufacturing, Process Control, FMEA
Fishers, Indiana, United States · On-site
Job DetailsJob Location: BANGS IN - Fishers, IN 46255Position Type: Part TimeJob Shift: DayWho We Are Ott Scientific The Ott Scientific family of companies comprises Polysciences, Bangs Laboratories, and Ethos Bioscience…
Skills: Facility Maintenance, Cleaning, Groundskeeping, HVAC Coil Cleaning, DI Water System Maintenance
Fishers, Indiana, United States · On-site
$75k–$95k
Deviation Writer Summary INCOG BioPharma Services is seeking an experienced and detail-oriented Deviation Writer to join our team. This role is crucial for translating a variety of complex technical events into clear, ac…
Skills: Technical Writing, Root Cause Analysis, GMP Compliance, Deviation Management, Ishikawa Fishbone
Fishers, Indiana, United States · On-site
About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. As a company, we con…
Skills: P&L Management, Leadership, Cross-team Collaboration, Inventory Reconciliation, Performance Management
Fishers, Indiana, United States · On-site
$60k–$75k
Shipping Specialist Summary We are seeking a highly organized and detail-oriented individual to join our team as a Shipping Specialist. The successful candidate will play a crucial role in ensuring the safe and efficient…
Skills: Pharmaceutical Shipping, cGMP, cGDP, ERP Systems, Material Management Systems
Fishers, Indiana, United States · On-site
INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. The Equipment Specialist is a key…
Skills: Sterile Pharmaceutical Manufacturing, Industrial Automation, GMP Manufacturing, Aseptic Processing, Equipment Troubleshooting
Fishers, Indiana, United States · On-site
$113k–$132k/yr
Elevate is committed to providing the highest quality commercial roofing, wall and lining systems to solve our customers’ challenges, grounded by a 45-year legacy of proven experience. Our mission is to deliver solutions…
Skills: Spectroscopy, Chromatography, Rheology, Data Analysis, SOP Authoring
Fishers, Indiana, United States · On-site
$27/hr–$25/hr
Inspection Associate Summary INCOG BioPharma Services is seeking a subject matter expert (SME) with capabilities in the inspection and of sterile drug products. The Inspection Associate is a key role within the organizat…
Skills: Sterile Drug Product Inspection, cGMP Compliance, Visual Inspection, Pharmaceutical Packaging, SOP Adherence
Fishers, Indiana, United States · On-site
$113k–$132k/yr
Elevate is committed to providing the highest quality commercial roofing, wall and lining systems to solve our customers’ challenges, grounded by a 45-year legacy of proven experience. Our mission is to deliver solutions…
Skills: Spectroscopy, Chromatography, Rheology, Polymer Manufacturing, Data Analysis
Fishers, Indiana, United States · On-site
$100k–$120k
The Manufacturing Supervisor is responsible for overseeing production operations, ensuring that all work completed is within appropriate timeframes, delivering daily expectations and assignments. Providing on floor suppo…
Skills: Production Oversight, cGMP Compliance, Aseptic Techniques, People Leadership, Batch Planning
Fishers, Indiana, United States · On-site
$100k–$120k
The Manufacturing Supervisor is responsible for overseeing production operations, ensuring that all work completed is within appropriate timeframes, delivering daily expectations and assignments. Providing on floor suppo…
Skills: Production Oversight, cGMP Compliance, Aseptic Techniques, People Leadership, Batch Planning
Fishers, Indiana, United States · On-site
$75k–$90k
Weekend QC Scientist Summary The Weekend QC Scientist supports GMP manufacturing and laboratory operations by performing routine microbiology and chemistry testing, sample handling, and laboratory support activities unde…
Skills: Microbiology Testing, Chemistry Testing, GMP Compliance, Good Documentation Practices, Sample Handling
Fishers, Indiana, United States · On-site
$70k–$85k
Quality Control Chemist Summary: INCOG is seeking a Quality Control (QC) Chemist with a passion for working within a team, a desire to drive Quality processes in a regulated setting, and a commitment to upholding the int…
Skills: UHPLC/HPLC, GC, SoloVPE, UV-VIS, TOC
Allen County, Indiana, United States · Hybrid
$41k–$98k/yr
Be a part of our mission! As a world leader in creating comfortable, sustainable, and efficient climate solutions for buildings, homes and transportation, it's our responsibility to put the planet first. For us at Trane …
Skills: Customer Advocacy, Account Management, Inside Sales, Salesforce, Customer Retention
Allen County, Indiana, United States · On-site
$99k–$143k/yr
Be a part of our mission! As a world leader in creating comfortable, sustainable, and efficient climate solutions for buildings, homes and transportation, it's our responsibility to put the planet first. For us at Trane …
Skills: Account Management, Solution Sales, Lead Generation, Customer Relationship Management, Market Analysis
Fishers, Indiana, United States · On-site
Job ID: 14267 Alternate Locations: Newell Brands is a leading consumer products company with a portfolio of iconic brands like Graco®, Coleman®, Oster®, Rubbermaid®, Sharpie® and Yankee Candle® - and 24,000 talented team…
Skills: Lean Principles, Six Sigma, CAD, AutoCAD 3D, SAP
Fishers, Indiana, United States · On-site
$21/hr–$28/hr
Job Summary The Quality Control Technician will be a member of the Quality Control Department. As a member of the team, he/she/they will be involved in routine QC sampling and testing of utilities, raw materials, in-proc…
Skills: QC Sampling, GMP, Analytical Chemistry, Sample Management, Equipment Calibration
Fishers, Indiana, United States · On-site
$21/hr–$28/hr
Job Summary The Quality Control Technician will be a member of the Quality Control Department. As a member of the team, he/she/they will be involved in routine QC sampling and testing of utilities, raw materials, in-proc…
Skills: QC Sampling, GMP, Analytical Chemistry, Sample Management, Equipment Calibration
Fishers, Indiana, United States · On-site
Job ID: 13890 Alternate Locations: Newell Brands is a leading consumer products company with a portfolio of iconic brands like Graco®, Coleman®, Oster®, Rubbermaid®, Sharpie® and Yankee Candle® - and 24,000 talented team…
Skills: Machine Repair, Mechanical Troubleshooting, Preventative Maintenance, Equipment Installation, LEAN Manufacturing
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The Deviation Writer is responsible for translating complex technical events into clear, robust investigations and root cause conclusions. They collaborate with cross-functional teams to implement effective corrective and preventative actions to prevent future non-conformances.
Requires a Bachelor's degree in a scientific, engineering, or technical discipline and at least 3 years of technical writing experience in a regulated GMP environment. Proficiency in electronic Quality Management Systems and Microsoft Office is essential.
We are looking for an Engineering Technical Writer who is a detail-oriented documentation professional with a strong technical background and a thorough understanding of GMP documentation standards in a regulated pharmaceutical manufacturing environment. Embedded within INCOG BioPharma's Engineering and Technical Operations team, the Engineering Technical Writer is the primary owner of engineering documentation quality, consistency, and compliance.
This role partners closely with Production Engineers, Process Engineers, Manufacturing Equipment Technicians, Quality Assurance, Technical Services, and Operations to translate complex technical content into clear, accurate, and audit-ready documentation. The Engineering Technical Writer plays a critical role in ensuring that INCOG's engineering documentation infrastructure supports operational excellence, regulatory readiness, and long-term institutional knowledge across all manufacturing areas and suites.
· Author, revise, and maintain engineering GMP documentation (SOPs, work instructions, prep forms, IQ/OQ/PQ protocols/reports, validation documents, engineering specs, and functional design documents) in accordance with cGMP and INCOG standards, collaborating with Production Engineers, Process Engineers, Manufacturing Equipment Technicians, and SMEs to translate technical input into clear, compliant content
· Manage the full document lifecycle in INCOG's DMS (initiation, periodic review, revision control, approval routing, and retirement), including change control documentation coordinated with Quality, Manufacturing, and Engineering to ensure change packages are complete and inspection-ready
· Structure and draft deviation investigations, root cause analyses, and CAPA documentation, and provide technical writing support for master batch record sections covering equipment setup, cleaning, and operation
· Develop engineering training materials, job aids, and visual work instructions to support competency development across PrE, PE, and MET teams
· Conduct document gap assessments and periodic reviews, applying INCOG's documentation style standards to resolve discrepancies and maintain consistency across engineering documents
· Serve as a documentation readiness resource during internal/client audits and regulatory inspections, and maintain an organized, traceable documentation library with indices and metadata for efficient retrieval
· Work flexible hours to support manufacturing facility coverage as needed
· Bachelor’s degree in a scientific, engineering, or technical discipline.
· Minimum of 3 years of experience in technical writing within a regulated GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries.
· Proficient in writing clear, concise, and accurate technical documentation.
· Strong understanding of GMP manufacturing processes and regulatory requirements.
· Excellent organizational skills with high attention to detail.
· Ability to collaborate effectively with cross-functional teams and communicate complex information to diverse audiences.
· Familiarity with documentation tools and electronic document management systems (EDMS).
· Exceptional computer skills, particularly moderate to expert level experience with Microsoft Word and Microsoft Excel.
· Ability to manage multiple projects and deadlines simultaneously.
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 85 open manufacturing positions in Fishers, IN listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include INCOG BioPharma Services, Thermo King, Amrize, Inovar Packaging Group, Newell Brands, among others. Browse the listings above to see every active employer.
Yes — 6 of the 85 open manufacturing positions offer remote or hybrid work (1 remote, 5 hybrid).
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.
