Engineering Jobs in Noblesville, IN
13 positions found
Schedule: Saturday - Wednesday, 12AM - 8:30AM, (2 - 4 week training period will be Monday - Friday, 8AM - 4:30PM)
Pay: $22 - 26.50/hr. (DOE)
Type: Contract to Hire
Job Functions:
- Troubleshoot electrical, hydraulics, pneumatics and mechanical system in an industrial environment.
- Determines best course of action to make repairs. Sets and/or adjusts priorities to ensure safety and reliability of production equipment and support systems.
- Test equipment after repairs and leave equipment and area in a clean, safe condition.
- Perform functionality and alignment checks; make adjustments, modifications, and replacements as directed.
- Work from schematics, engineering drawings, and written or verbal instructions.
- Operate related equipment, conduct tests and report data in prescribed format.
- Use predetermined methods, sequences, and setups to inspect or test specific equipment or product; making modifications and adjustments as necessary.
- Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP’s.
- 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.).
- Two-year degree in Electrical Automation, Industrial Maintenance, Electronics, Electrical systems, or related field required, or equivalent training in Armed Forces training schools.
- One or more years of relevant work experience in maintaining, troubleshooting, and repairing industrial equipment and/or automation systems, preferably in pharmaceutical manufacturing equipment.
- Strong troubleshooting skills, with and without schematics.
- Use of voltmeter and other general-purpose test equipment
- AC/DC electrical power systems / supplies (Preferred)
- Industrial manufacturing equipment, automated systems (Preferred)
- Automation electronics, electrical controls / PLCs.
- Proximity and optical sensors, signal wiring / connectivity.
- AC/DC motors
- Pneumatics, hydraulics and associated controls.
- Vacuum pumps / systems
- Electro-mechanical systems
- Equipment calibration experience.
- Building Management Systems
- Reverse engineering
- Root Cause Analysis experience.
- Basic soldering experience.
#IND-SPG
Estimated Min Rate: $22.00
Estimated Max Rate: $26.50
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:
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.).
- 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:
WHO?
INCOG BioPharma Services is seeking an experienced and detail-oriented Deviation Writer to join our Manufacturing Engineering team. This role is crucial for translating a variety of complex technical events into clear, accurate, and robust investigations. The Deviation Writer will work closely with the Manufacturing, Production Engineering, Manufacturing Sciences and Technology, Supply Chain, Quality, and other cross-functional teams to create comprehensive investigations that leverage facts and data to support robust root cause conclusions, effective corrective actions, and systematic all-encompassing preventative actions. The Deviation Writer will exemplify excellent interpersonal skills and be capable of developing productive customer-centric working relationships with internal and external customers and have a role with high visibility to all departments. The Deviation Writer will have strong familiarity with industry standard electronic Quality Management System(s) and Microsoft Office suite products.
They will thrive working autonomously utilizing strong self-management and organization skills but also be able to interact, collaborate, and lead within a team environment. The Deviation Writer will value the processes owned by internal customers and subject matter experts and will possess a demonstrated ability to support and influence positive outcomes in the application of that knowledge to wider processes.
There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.
At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.
Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.
WHAT?
- Understand, investigate, and author a variety of deviating conditions or nonconforming events across multiple technical departments, in alignment with Subject Matter Experts.
- Self-motivated to fact gather, analyze information, interpret data, utilize expertise from Subject Matter Experts, etc. in an effort to provide supportive evidence to the investigation and root cause.
- Experience utilizing a variety of analysis tools to support root cause identification; Ishikawa Fishbone, 5 Why, etc.
- Ability to critically think outside the box for robust corrective and preventative actions; leveraging automation and engineering controls to error-proof equipment and processes.
- Demonstrated ability to translate complex, technical processes and descriptions into simplified, understandable write ups.
- Eagerness to collaborate and partner with both internal and external stakeholders to comprehensively represent the facts of an investigation in a logical and presentable manner.
- Evaluating historical deviating conditions, adverse events, non-conformances, etc. in order to identify and prevent trends.
YOU!
- 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.
Additional Preferences:
- 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.
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.
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
The Project Manager position at Engineered Facades reports directly to the Executive Vice President. The primary responsibility of the position is the planning, management, customer satisfaction, and financial success of construction projects.
Responsibilities
- Providing overall project coordination, planning, and scheduling
- Comply with quality standards for product procurement and delivery
- Maintain schedule and deliver projects on time
- Send/manage/maintain project management documentation
- Monitor resource allocation and manage labor, materials, and equipment
- Prepare and manage change orders, submittals, RFIs, and contracts
- Manage punch-list completion and project close-out including warranties and other documents
- Perform regular jobsite visits
- Continuing education to develop personally and build a knowledge of base of the various materials and systems the company installs
- Attend company meetings as necessary
- Other duties as assigned
Qualifications
Has relevant experience working in the construction industry for at least five years. Skills for this position include:
- Knowledge of construction principles, techniques, and procedures
- Excellent communication skills and organizational skills
- Proven ability to manage multiple projects and meet deadlines in a timely fashion
- Strong interpersonal skills and able to work in a team environment
- Experience with Microsoft Office Suite
- Abillity to read architectural plans and specifications
- CPM scheduling experience and estimating experience beneficial
- Ability to travel on occasion per project requirements
ABOUT US
Envoy has been serving communities across the state of Indiana with high-end and community focused development and construction projects for the last 40+ years. We are a multifaceted company driven to enrich our communities and our team. We are a team of collaborative self-starters. We value commitment and transparency while standing by our family-like company culture.
JOB SNAPSHOT
The Pre-Construction Manager leads the planning and budgeting phases of assigned projects, guiding design teams through programmatic, schematic, design development, and construction documentation. This role requires strong professional communication and collaboration with municipal agencies, owners, developers, architects, designers, and subcontractors. The Pre-Construction Manager works to develop, update, and validate project budgets and historical cost data.
RESPONSIBILITIES
Preconstruction Planning & Budgeting
- Manage estimates, budget development, risk analysis, and client communication throughout all preconstruction phases.
- Prepare and refine quantity take-offs, cost estimates, and cost analyses in collaboration with the Chief Estimator.
- Ensure strict adherence to design parameters by obtaining and reviewing plans and related documentation.
- Maintain and update historical cost databases and project estimate records.
- Accurately present job costs, schedule updates, and budget adjustments at defined intervals.
Project Documentation & Procurement
- Assist with the preparation of RFQs/RFPs, scope-of-work packages, and bid documents.
- Upload, organize, and maintain bid documentation using internal and external procurement platforms.
- Support subcontractor buyout and award processes across multiple project delivery methods.
- Maintain and update master scope-of-work templates for all subcontract bid categories.
Coordination & Communication
- Lead internal team meetings, design progress discussions, and budget review sessions.
- Collaborate with owners/developers to secure required building permits and ensure compliance with local codes.
- Manage and facilitate value engineering and value-management sessions for all assigned projects.
- Work jointly with the Chief Estimator, architects, clients, and vendors to ensure clear communication and alignment.
Administrative & Financial Responsibilities
- Develop and manage preconstruction schedules.
- Oversee monthly billings and ensure compliance with cost procedures during preconstruction.
- Uphold and promote the company’s core values, contributing positively to organizational culture.
REQUIRED QUALIFICATIONS
- Bachelor’s Degree in Construction Management, Building Construction, Engineering, or a related discipline preferred, but not required.
- Minimum 3 years of experience in public/private commercial construction, development, or estimating.
- Estimating software: Destini, Planswift, Onscreen or other similar takeoff software.
- Project manager software: Procore or similar construction management software.
- Scheduling: MS Project and outbuild.
- Document Management & Collaboration: Google Workspace (Gmail, Drive, Sheets, Docs), PDF markup/annotation tools, Bluebeam Revu, word, and excel proficiency.
- Bid Management: Building Connected or similar procurement platforms.
- Proven ability to produce conceptual and schematic budgets ranging from $5M–$50M.
- Ability to prepare conceptual site and building phasing plans for presentations.
- Ability to understand project processes and standard progression for construction projects including document control.
- Strong fluency in reading plans, interpreting specifications, and navigating project documentation.
- Excellent written and verbal communication skills across diverse project teams.
- Effective dispute resolution skills with the ability to reach timely, mutually satisfactory outcomes.
- Highly organized, detail-oriented, and able to manage multiple time-sensitive tasks.
- Commitment to continuous learning and willingness to take on increasing responsibilities.
- Ability to work collaboratively with internal and external partners, including design teams and vendors.
- Must pass a criminal background check
COMPENSATION & BENEFITS
- Top-notch, competitive compensation packages that keep up with ever-changing markets.
- Company-sponsored retirement packages, available during the open enrollment period, after the completion of your first year.
- A flexible Paid Time Off program that focuses on family and mental health.
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.
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
- Evaluate and implement new changes
- Participate and/or support process FMEAs to understand process and product risks as a pre-requisite for process validation.
- Provide technical support to manufacturing activities
- Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence.
- Partner with vendors and suppliers to define requirements and understand functional specifications
- Work flexible hours to ensure production facility coverage
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
Additional Preferences:
- Lean Six Sigma Certification
- Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices
- Applicable experience with process design, data integrity, controls, instrumentation, and electro-mechanical systems
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.
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.
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.
