Engineering Journal Jobs in Fishers, IN

24 positions found — Page 2

Maintenance Manager
Salary not disclosed
Noblesville, IN 2 days ago
Yoh is hiring a Maintenance Manager for our Pharmaceutical Manufacturing client in Noblesville, Indiana. This is a great opportunity to join a growing team!

Summary of Position
Responsible for the Safety, Quality and Cost Effectiveness of the maintenance activities within the manufacturing and building facilities operations in their area. Responsibilities include supervising, directing and coordinating the maintenance activities within the area as well as the direct supervision of Maintenance Technicians.  

Job Functions:
  • Effectively supervise and guide the maintenance activities of Technicians who are responsible for pharmaceutical production equipment/pharmaceutical facility support equipment and facilities.  
  • Conduct maintenance in accordance with FDA guidelines, Good Manufacturing Practices, Controlled Change Management, and all internal and external required regulations pertaining to Good Maintenance Practices.
  • Evaluate and assign work orders to properly skilled technicians.  Manage emergency equipment repairs by problem assessment, problem solving and assignment of work to properly skilled technicians.
  • Responsible for the adherence, processing and tracking of maintenance related documentation, including policies/procedures, SOP’s, PM/DM reports, deviation reports, change control documents, overdue reports, retired and inactive records, and PM/DM planning schedules.
  • Assist in maintaining accurate maintenance records through an active interface with the computerized maintenance management system (CMMS) during work execution and closeout for work history documentation.
  • Provide training and leadership to direct reports on all daily duties they are assigned with initial and periodic assessments.  
  • Manage capital and major maintenance projects within approved dollar limits.
  • Demonstrate knowledge of 5S, TPM and its implementation in an operating environment.
  • Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Requirements
  • B.S degree required.  Preferably in Chemical, Mechanical, or Electrical Engineering.
  • 12 or more years of relevant experience in maintenance management and supervision in a pharmaceutical industry required.
  • Extensive knowledge of cGMP, FDA, OSHA, and NRC regulations preferred.


Schedule: 
 Mon – Fri   7am -4pm
Salary: $95 - 130K (DOE)

#IND-SPG

Estimated Min Rate: $95000.00
Estimated Max Rate: $130000.00

What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

  • Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
  • Health Savings Account (HSA) (for employees working 20+ hours per week)
  • Life & Disability Insurance (for employees working 20+ hours per week)
  • MetLife Voluntary Benefits
  • Employee Assistance Program (EAP)
  • 401K Retirement Savings Plan
  • Direct Deposit & weekly epayroll
  • Referral Bonus Programs
  • Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: 

Not Specified
Plant Manager
Salary not disclosed

Bell & Associates is seeking a Plant Manager in the Food & Beverage Industry in the Greater Noblesville, IN Area (160-210K Annual Salary plus 25% Bonus)


The Plant Manager will direct and manage all day-to-day plant operations activities, processes, projects and administrative activities. They will be responsible for developing and implementing strategies and tactics that create opportunities for the company.


Responsibilities will include, but not be limited to the following:

  • Reporting of timely and accurate plant operations reports to management
  • Direct and coordinate the plant’s strategic planning and annual budgeting process including capital expenditures and corresponding ROI
  • Provide leadership, inspiration, guidance and counsel to foster and facilitate cost-control, revenue growth, increased profitability and creation of value
  • Mentor, lead, inspire and counsel employees on personal and professional growth and development
  • Direct the activities of the plant operations to support all customer needs, business needs and future growth
  • Capable of handling multiple priorities simultaneously and promptly.


Qualifications:

  • 10+ years of proven and progressive plant management experience in high speed food & beverage or similar industry
  • Outstanding track record and reputation for business acumen, business judgment, quantitative analysis ability, leadership skills and integrity.
  • Demonstrated knowledge of lean manufacturing or continuous improvement principles is extremely desirable; as is production scheduling, technical aptitude, and project management expertise.
  • Experience with both branded and private label products is desirable.
  • Preferred: Engineering or technical experience in a high speed production environment
Not Specified
Formulation Specialist - Weekend Shift Days and Nights (Pharma - Liquid Drug Product)
Salary not disclosed
Carmel, IN 2 days ago

Aseptic Fill/Finish | Liquid Drug Product


Weekend Day Shift -> Friday - Sunday from 6am to 6pm (2 openings)

Weekend Night Shift -> Friday - Sunday from 6pm to 6am (2 openings)


Full-time, Direct Hire with Full Benefits


A pharmaceutical manufacturing organization is seeking a Formulation Specialist to support bulk drug product preparation within an aseptic sterile fill/finish environment. This hands-on role is responsible for formulation, equipment operation, and cGMP manufacturing activities supporting aseptic production.


The position works closely with manufacturing, quality, and technical teams to ensure safe, compliant, and efficient batch execution while contributing to process improvements and operational excellence.


Key Responsibilities

  • Perform weighing, dispensing, and formulation activities for liquid drug product manufacturing
  • Set up, operate, clean, and maintain formulation and processing equipment
  • Execute manufacturing operations within controlled and cleanroom environments
  • Complete batch documentation and manufacturing records in accordance with cGMP requirements
  • Support aseptic filling operations and equipment preparation as needed
  • Assist with validation runs, engineering batches, and process troubleshooting
  • Train and support team members on manufacturing procedures and best practices
  • Participate in continuous improvement and equipment optimization initiatives
  • Collaborate cross-functionally to ensure production timelines and quality standards are met


Basic Qualifications

  • High school diploma or equivalent required
  • Minimum 1+ year of GMP pharmaceutical manufacturing experience or 3+ years of related manufacturing experience
  • Experience operating and maintaining production equipment in a regulated environment
  • Basic computer proficiency (Microsoft Office and similar systems)


Preferred Background

  • Bachelor's Degree with a Scientific focus (not required)
  • Experience in sterile or aseptic pharmaceutical manufacturing environments
  • Knowledge of cGMP regulations and good documentation practices
  • Familiarity with SAP/ERP or inventory management systems
  • Strong communication skills and attention to detail


Work Environment

  • Pharmaceutical manufacturing facility supporting sterile drug product production
  • Cleanroom and controlled manufacturing areas required (Grade A and Grade C)
  • Hands-on production role with weekend schedule coverage
Not Specified
Community Maintenance Landscape Manager
Salary not disclosed
Carmel, IN 3 days ago

Community Maintenance Landscape Manager

Primary Function:

The Community Maintenance and Landscape Manager (the “CMLM”) will be primarily

responsible for overseeing the aesthetics of all Old Town residential communities which

includes amenity and landscape planning and installation for new communities, repair and

upkeep of existing communities, and general oversite of the various property owners’

associations in partnership with our third-party management vendors. In collaboration with

the Project Executive over Land Development, the CMLM owns the fulfillment &

maintenance of the design aesthetic for each community Old Town develops.

Contribution to Company Mission and Vision:

The CMLM shall work collaboratively to ensure that the Company continues to create

communities that flourish, while supporting the foundational principles of pursuing

outstanding locations and timeless designs. The CMLM shall maintain the integrity of the

Old Town brand in all aspects of their position while contributing to the values of gratitude,

ownership, perseverance, accountability and innovation.

Role Absolutes:

1. Be involved in landscape design & Lead long-term landscape maintenance of

the community

2. Manage Builders

3. Own the release of Maintenance Bonds

Primary Responsibilities:

Work with the leadership team to participate in early land planning exercises to understand the

overall needs of the community and inform planning based on existing communities.

Accomplish the stated project objectives within the stipulated time of all assigned

projects.

Ensure that all project requirements are completed; at the same time ensure that quality,

cost and time are properly managed.


Document and store lot conditions through pictures.

Secure competitive bids and make award recommendations of responsive/responsible

contractors.

Supervise subcontractors for compliance with construction documents, quality

requirements and critical path schedule.

Review/approve payment of subcontractor pay applications and purchase orders

Supervise Grounds Maintenance Manager for successful pre and post lot inspections & on-going

community maintenance for the remaining life cycle of the development, post

construction turnover

Assist in developing accurate cost projections; scope, budget and schedule.

Monitor and coordinate the work effort of all consultants and subcontractors to ensure

their scope of work is in conformance with the project budget, schedule, and development

guidelines.

Schedule maintenance and repairs, regularly inspect property to ensure it is in good

working order, quickly resolve emergency maintenance issues in coordination with the

Grounds Maintenance Manager.

Keep open dialogue with Owners on vacancies, tenants, physical condition of property and

financial issues.

Maintain property by investigating and resolving complaints, completing repairs, and

contracting with landscaping and snow removal services.

Participate in HOA meetings in support of the Community Manager role.

Support the Community Manager role in accurate budget creation and adherence to

operating budgets.

Architecture Review Board – attend bi-weekly ARB meetings and coordinate architectural

approvals in partnership with legal administrator.

Serve on ARB providing detailed input on all builder plan submissions to the board.

Review homebuilder landscape plans for approval for each community that Old Town

manages and confirm installation per plan.

Manage all property owner maintenance issues that fall outside of the HOA property

management services agreement.

Maintain building systems by contracting for maintenance services and supervising repairs

for all Old Town owned properties not managed by third party services (HQ, Field Office,

future development sites).

Provide accurate documentation, reporting, and data collection to ensure compliance with

any financial reporting requirements.

Maintain maintenance logs and report on activities per property/community.

Ensure health and safety policies are in compliance.

Attend weekly/monthly/quarterly project meetings with agendas that include status

updates and tasks to be accomplished.

Other duties as assigned

Education and Experience:

• Minimum high school diploma or equivalent required.

• Valid, unrestricted driver’s license and good driving record required.

• Minimum 5 years in construction, development design and/or land & site

development.

• Must be able to read, understand and evaluate civil engineering, dry utility, and

landscape plans.

• Good written, oral, organizational and math skills.

• Must possess professional attitude to represent the company in a positive manner.

• Ability to perform multiple detail-oriented tasks with simultaneous deadlines in a

professional matter.

• Knowledge in Microsoft Office (Word, Excel) and Microsoft Project a plus.

• Excellent project management, organizational, time management, and planning

skills. Strong customer service skills are a plus.

Reporting:

The Community Maintenance and Landscape Manager will report directly to the Land

Development Project Executive.

Not Specified
Senior Consultant / Manager
Salary not disclosed
Fishers, IN 3 days ago

Senior Consultant / Manager – Supply Chain Design

Fishers, IN (Hybrid: 3 days in office, 2 remote)


We are seeking an experienced Senior Consultant / Manager to lead complex supply chain design and transformation projects. This role combines advanced analytics, executive-level advisory, and team leadership to deliver measurable business impact.


You’ll serve as a trusted advisor to VP and C-suite stakeholders, translating complex data into actionable strategies while mentoring high-performing consulting teams.


What We’re Looking For

  • Bachelor’s or Master’s degree in Engineering, Supply Chain, Operations Research, or related field
  • 8+ years of experience in supply chain design, optimization, or analytics
  • Proven success leading consulting engagements and managing stakeholders
  • Experience with large-scale supply chain transformation initiatives
  • Strong modeling expertise (Coupa/LLamasoft, AIMMS, RiverLogic)
  • Proficiency in Python or SQL; familiarity with Gurobi/CPLEX a plus
  • Experience with Power BI or Tableau
  • Strong executive presence and communication skills


What’s Offered

  • High-visibility leadership role in a growing market
  • Ownership of transformative, large-scale projects
  • Comprehensive benefits including medical, dental, vision, 401(k), and PTO
  • Global exposure and professional development opportunities
  • Collaborative, performance-driven culture


This is an excellent opportunity for a strategic supply chain leader who thrives in a consulting environment and enjoys driving data-driven transformation at scale.

Not Specified
Facade Engineering and Design Manager
Salary not disclosed
Noblesville, IN 1 week ago

Engineered Facades is a high-value provider of architectural building exteriors. Our knowledgeable, dedicated associates work professionally with an exclusive group of vendors and customers in an environment built on commitment and trust.


Job Description

The Design Manager position at Engineered Facades reports directly to the Director of Design and Engineering. The Design Manager coordinates and exercises functional planning, organization, control, integration and completion of engineering projects within the area of assigned responsibility.

  • Manages the draftsmen and schedules their work.
  • Reviews design for compliance with engineering principles, company standards and contractual requirements, and related specifications.
  • Coordinates activities concerned with technical developments, scheduling and resolving engineering design challenges.
  • Reviews drawings, specifications and related data for accuracy and completeness.
  • Performs technical reviews of shop drawings, FAB tickets and construction administration submittals to ensure air, water, thermal, and structural performance
  • Coordinates façade calculations with third party engineering firm.
  • Analyze structural integrity on basic wall systems without involving third party engineering firm
  • Collaborates with and provide production support to the architectural drafters
  • Works with QA to resolve issues with engineering design problems
  • Uses computer assisted design/drafting equipment and software to develop designs.
  • Creates fab tickets and cut lists for projects
  • Develops design solutions to fit within budget and timeline


Requirements

Bachelor’s degree in Civil Engineering, Structural Engineering or Mechanical Engineering or Building Construction Management or related degree and at least five- ten years’ experience in the construction industry. Other skill sets for this position include:

  • Excellent communication skills and organizational skills
  • Knowledge of construction principles, techniques and procedures
  • Proven ability to manage multiple projects and meet deadlines in a timely fashion
  • Strong interpersonal skills and able to work in a team environment
  • Construction related software program knowledge including: Auto-CAD and Autodesk Inventor
  • Experience in Sketch Up
  • Ability to sketch rough layouts, details and computes angles, weights, surface areas, dimensions, radii, clearances, tolerances, etc.
  • Strong organizational and problem solving skills.
  • Proficient mathematical skills.
  • Proficient use of Microsoft Office Suite.
Not Specified
Production Engineer
Salary not disclosed
Fishers, Indiana 1 week ago

Production Engineer

WHO?

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 support the technology road map.

The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling, sterile manufacturing, and engineering principles.

This is a 2nd shift position.

WHAT?

  • Resolve issues that arise per daily operation and provide timely responses and solutions
  • Implement solutions in collaboration with cross-functional technical teams and site leadership
  • SME for filling equipment and supporting systems
  • Evaluate and improve efficiency of manufacturing instruments, equipment, and tools

YOU!

  • Bachelor's degree in engineering field or life sciences with 5+ years of relevant work experience
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and process development
  • Hands-on experience troubleshooting, repairing and performing preventative maintenance of manufacturing equipment

Why INCOG?

  • Paid time off, based on tenure
  • 11 paid holidays
  • 401(k) plan with company match up, vested immediately
  • Choice of health & wellness plans
  • FSA and HSA options
  • Onsite wellness facility
  • Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don't meet all the requirements? Don't sweat! We're always looking for an excuse to discuss your next opportunity. You might just surprise yourself...

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

Not Specified
Nuclear Engineer
Salary not disclosed
Fortville, Indiana 1 week ago

Job Title : Nuclear Engineer (Naval Reactors Engineer) Category / Component : Officer • Active Overview Design, regulate, and oversee the Navy's nuclear propulsion program, including reactor design, fleet operations, and eventual defueling and decommissioning of nuclear powered ships and submarines from Naval Reactors Headquarters and associated Department of Energy laboratories and shipyards.

Key Responsibilities Provide technical direction in areas such as reactor and fluid systems design, reactor physics, materials development, component design for steam generators, pumps, and valves, instrumentation and control for reactor and propulsion plants, testing and quality control, radiation shielding, and chemistry and radiological controls; review designs and analyses from laboratories, shipyards, and industry partners; coordinate with fleet units to ensure safe and reliable nuclear plant operation.

What to Expect Assume significant technical responsibility early in your career as part of a lean headquarters staff; work primarily in an analytical and oversight role rather than operating plants at sea; balance long term engineering projects with time sensitive fleet and shipyard issues; frequent coordination with senior civilian engineers, naval officers, and technical teams; high expectations for attention to detail, judgment, and written and oral communication.

Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of Columbia area with regular engagement with Department of Energy laboratories, nuclear training sites, shipyards, and nuclear powered ships and submarines; office based work that includes document reviews, technical meetings, inspections, and site visits rather than day to day shipboard watchstanding.

Pathways, Training & Advancement Officer commissioning through programs such as Officer Candidate School or the Nuclear Propulsion Officer Candidate program followed by a structured technical qualification program at Naval Reactors; rotational exposure to laboratories, prototypes, shipyards, and fleet support issues; progressive responsibility leading projects and becoming a subject matter expert, with opportunities for professional military education and advanced graduate study in technical fields.

Entry through the Nuclear Propulsion Officer Candidate program for qualified college students and recent graduates, or selection via Officer Candidate School for those who already hold qualifying degrees; all applicants must meet Nuclear Propulsion Program academic and technical screening standards in addition to general officer commissioning requirements.

Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.

Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.

Additional qualifications for this job may include: Completion of a rigorous technical degree in engineering, physics, mathematics, or a closely related field that includes strong backgrounds in calculus and physics; outstanding academic record, particularly in technical coursework; United States citizenship and eligibility for a high level security clearance; strong technical aptitude and comfort with detailed analytical work.

Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.

Specific options depend on the Sailor's status, training, and current Navy policy.

Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.

Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.

Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.

Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.

Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.

It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.

Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.

Not Specified
Senior SEO Specialist & Copywriter
Salary not disclosed
Carmel, IN 1 week ago

This position is required to be fully in-person at our headquarters in Carmel, Indiana.


Overview

We are seeking a highly motivated and versatile Senior SEO Specialist & Copywriter to join our marketing team. This position is focused on driving brand visibility, digital reach, and engagement through strategic, high-impact content.

You will own the company’s SEO strategy to acquire qualified leads for both BAM Capital and BAM Management. In addition to SEO content, you will produce formal financial communications and conversion-driven marketing copy to strengthen BAM Capital’s digital presence and support investor acquisition and retention.

We are seeking a performance-oriented communicator to elevate The BAM Companies’ digital voice. The ideal candidate blends exceptional writing and editing skills with years of hands-on SEO expertise, independently managing our content lifecycle across corporate and property websites while adapting our message for diverse audiences.


Key Responsibilities

Search Engine Optimization (SEO) Strategy & Execution

  • Sole SEO Management: Act as the company's dedicated SEO content expert, driving organic growth (traffic and leads) across BAM Capital for accredited investors and property websites for residents.
  • Keyword Research: Independently identify and analyze high-value, relevant keywords using industry-standard tools.
  • Content Strategy: Develop and maintain a comprehensive content calendar based on keyword opportunity, search intent, and business goals.
  • Article Production: Write, edit, and optimize detailed SEO articles that rank highly, drive organic traffic, and convert readers.
  • Performance Reporting: Track, analyze, and report on key SEO metrics (e.g., traffic, keyword rankings, conversion rate) to demonstrate ROI and inform future strategy.
  • Generative Engine Optimization: Stay up to date with and implement best practices to rank in AI search results.


Corporate & Financial Communications

  • Professional Offering Memorandums (OMs) & Asset Supplementals: Draft and meticulously edit complex, professional financial and corporate documents, ensuring accuracy, clarity, and compliance to regulatory standards (as applicable).
  • Quarterly Performance Reports: Develop clear, concise, and compelling reports for external audiences that summarize company performance and strategic outlook.
  • Award Nominations: Research, write, and submit persuasive applications for industry award nominations.
  • Executive Communications: Draft high-impact social media posts and professional communications for the CEO and other executives, including market insights and thought leadership pieces.


Marketing & Sales Content

  • Website Copy & Brochures: Write and optimize engaging, clear copy for the corporate and property websites and marketing brochures. Keep websites up to date with frequent content reviews.
  • Product Content: Create concise, informative product one-pagers and sales enablement materials for BAM Capital.
  • Marketing Emails: Develop compelling email marketing copy for various campaigns (e.g., nurture, announcement, informative).
  • Advertisements: Work with the internal PPC Specialist and Lead Generation Manager to develop high-converting copy for multi-channel advertising campaigns. Craft compelling headlines and calls-to-action that resonate with accredited investors, drive traffic to landing pages, and continuously A/B testing ad copy.
  • Additional Content: Produce blog posts, guides, and articles that position The BAM Companies and BAM Capital as thought leaders


Required Qualifications

  • Bachelor's degree in Marketing, Communications, Journalism, English, or a related field.
  • Minimum of 5 years of professional content writing experience, with a portfolio demonstrating a wide range of content types.
  • Demonstrated experience writing complex corporate or financial documents (e.g., quarterly reports, white papers, offering materials).
  • Minimum of 3 years of proven, hands-on expertise in SEO content strategy, including proficiency with major SEO tools (e.g., Semrush, Ahrefs, Moz, Google Search Console).
  • Exceptional written and verbal communication skills, with a mastery of AP and MLA grammar, style, and professional tone.
  • A meticulous editor and proofreader with attention to detail skills.
  • Ability to manage multiple projects simultaneously, meet tight deadlines, and work independently with minimal supervision.
  • This role requires learning our industry in depth to successfully produce the required content.


Preferred Qualifications

  • Experience in a regulated industry (e.g., finance, real estate, healthcare).
  • Experience writing for a high-net-worth, business, financial, or luxury audience.
  • Familiarity with content management systems (CMS) like WordPress.
Not Specified
Manager Supplier Quality Assurance
🏢 Lead Candidate
Salary not disclosed
Fishers, IN 1 week ago

Manager Supplier Quality Assurance


WHO?


INCOG Biopharma Services in Indianapolis, IN is looking for a Manager Supplier Quality Assurance who will be at the forefront of expanding their supplier quality program and leading supplier quality management for all types of biologic drugs for their clients. This individual will shape quality systems, develop a high-performing team, and drive continuous improvement initiatives that directly impact patient safety and product quality. This role offers the opportunity to join INCOG's state-of-art CDMO during an exciting time of growth, contributing towards a better path to market for life-saving drugs.


WHAT?


  • Team Leadership & Development: Build, lead, and mentor a team of supplier quality professionals, establishing clear performance objectives, providing ongoing coaching, and fostering a culture of continuous improvement and regulatory compliance
  • Supplier Qualification & Management: Develop and execute comprehensive supplier qualification programs, including risk assessments, audits, and ongoing performance monitoring for raw materials, components, and contract services
  • Quality Systems Ownership: Maintain robust supplier quality management systems, including vendor approval processes, incoming inspection protocols, and supplier scorecards aligned with GMP requirements
  • Regulatory Compliance: Ensure all supplier quality activities comply with FDA and EMA regulations, ICH guidelines, and other applicable regulatory standards
  • Supplier Auditing: Plan and conduct comprehensive supplier audits, including pre-qualification, routine surveillance, and for-cause audits, ensuring thorough documentation and effective CAPA follow-up
  • Process Improvement: Identify and implement process improvements to enhance efficiency, reduce cycle times, and strengthen compliance while supporting the organization's rapid growth trajectory
  • Cross-functional Collaboration: Partner closely with Procurement, Manufacturing, Quality Control, and Regulatory Affairs teams to ensure seamless integration of supplier quality requirements into business operations
  • Risk Management: Conduct supplier risk assessments, develop mitigation strategies, and manage supply chain disruptions to minimize impact on manufacturing operations
  • Documentation & Reporting: Maintain comprehensive supplier quality documentation, generate performance metrics and reports, and present findings to senior leadership and regulatory inspectors
  • Change Control: Evaluate and approve supplier changes, ensuring appropriate risk assessment, validation activities, and regulatory notifications as required
  • Training & Knowledge Management: Develop and deliver supplier quality training programs, maintain subject matter expertise, and ensure team competency in evolving regulatory requirements


YOU!


Ideally, candidates will have a Bachelor's degree in Life Sciences, Chemistry, Engineering or a related field. You will also have 7+ years of pharmaceutical quality assurance with at least 3 years in supplier quality management.


  • Strong knowledge of FDA regulations (21 CFR Parts 210, 211, 600), EMA regulations, ICH guidelines, and GMP requirements related to quality assurance and quality systems.
  • Experience with supplier auditing, qualification, and ongoing management programs
  • Demonstrated ability to identify improvements to quality systems and to lead implementation of these improvements


Additional preferences are a Master's degree in a relevant field or advanced quality certifications (ASQ, Certified Auditor, etc.) GMP leadership experience of quality professionals is highly beneficial alongside an exposure to aseptic filling operations, sterile manufacturing and parenteral drug products.


WHY INCOG?


  • Paid time off, based on tenure
  • 11 paid holidays
  • 401(k) plan with company match up, vested immediately
  • Choice of health & wellness plans
  • FSA and HSA options
  • Onsite wellness facility
  • Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations


Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…


Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

Not Specified
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