Jobs
>
Marquand

    Senior Validation Engineer - Indianapolis, United States - PACIV

    PACIV
    PACIV Indianapolis, United States

    1 week ago

    Default job background
    Description

    PACIV is a renowned global firm specializing in industrial automation solutions, serving the Life Sciences, F&B, and Utilities sectors, with locations in Puerto Rico, the United States, and Ireland. Currently, the company is looking to hire a full-time Senior Validation Engineer for their USA office in Indianapolis.

    Job Description:

    • The Senior Validation Engineer will oversee the preparation, review, and approval of quality and validation documents, ensuring compliance throughout manufacturing operations. Responsibilities include executing the System Development Lifecycle (SDLC) for various equipment and systems supporting manufacturing, laboratories, and packaging processes. Specific tasks will be assigned based on the candidate's experience and client requirements.

    Position Requirements

    • Bachelor's degree in Engineering or a related Technical discipline
    • Minimum of eight (8) years of experience in Commissioning, Qualification, and/or Validation within regulated industries
    • In-depth understanding of system lifecycle deliverables, from Commissioning & Qualification (C&Q) to Computer System Validation (CSV) and System Retirement. This includes preparing various documents such as User/Functional Requirements, Design Specifications, Qualification Test Protocols, Process Validation, and support documentation.
    • Experience with standard industry processes, Packaging, Facilities/Utilities, Control Box equipment, BMS/CMS Systems, Lab Equipment, and Automated Filling, Assembly, and Delivery lines.
    • Familiarity with electronic document retention systems like Regulus, SharePoint, etc.
    • Knowledge of industry expectations and requirements related to CSV and C&Q standards.
    • Active participation in cross-functional teams and leading project initiatives to ensure timely and quality project delivery.
    • Ability to manage large product launches, small capital projects, and process improvement changes within the manufacturing systems.

    Desired Hard Skill Sets

    • Comprehensive understanding of process control systems-related documentation, CSV experience, Data Historian systems, and Project Management.

    Desired Soft Skills

    • Comfortable in a 24/7 manufacturing environment, team player, capable of handling high-pressure situations, result-oriented, strong interpersonal and communication skills, organized, with proficiency in MS Project and Excel.

    Other Requirements

    • Location: Indianapolis, IN
    • Travel: Up to 10% to various suppliers and OEM sites outside of Indianapolis
    • Compensation: Competitive Salary and Benefits Package including Medical, Dental, Vision, Life Insurance, 401K Plan, Holidays, Vacation, and Sick Time pay.
  • Performance Validation

    Validation Engineer

    1 day ago

    Performance Validation Indianapolis, United States

    About Us · Here at Performance Validation, Inc (PV) we have been providing Commissioning, Qualification, and Validation services to the life science industries for 35 years We are a 100% employee owned company with teams in Indiana, Michigan, Illinois, Kansas, Washington, and Nor ...

  • Insight Global

    Validation Engineer

    1 week ago

    Insight Global Indianapolis, United States

    Insight Global is looking for a mechanical or electrical engineer with validation experience. Any kind of HVAC experience is a plus. Will develop documentation/blueprints/designs and sequences of operation for evaluation and validation of existing and new HVAC systems. Will devel ...

  • Integrated Resources

    Senior Validation Engineer

    3 weeks ago

    Integrated Resources Indianapolis, United States

    Integrated Resources, Inc · Indianapolis, IN (Onsite) · Full-Time · Intent to convert after 90 days based on performance. · Pharmaceutical experience required. · Monday to Friday 8 am to 5 pm · Job Description: · How will you make an impact? · The Process Validation Engineer w ...

  • PSC Biotech

    Validation Project Engineer

    2 weeks ago

    PSC Biotech Indianapolis, United States

    Job Description · Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to ...

  • LanceSoft

    Senior Validation Engineer

    1 week ago

    LanceSoft Indianapolis, United States

    How will you make an impact?Intent to convert after 90 days based on performance. · Pharmaceutical experience required. · Monday to Friday 8am to 5pm · The Process Validation Engineer will mentor and support in the diagnoses and resolution of software, instrument, and process pro ...

  • Thermo Fisher Scientific

    Engineer III, Validation

    1 week ago

    Thermo Fisher Scientific Indianapolis, United States

    Job Description · As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and s ...

  • Maxonic

    Sr. Validation Engineer

    3 weeks ago

    Maxonic Indianapolis, United States

    Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr. Validation Engineer. · Job Description: · Position: Sr. Validation Engineer · Location: Indianapolis, IN · Duration: 9+ months · Work Schedule: ON ...

  • PSC Biotech

    Senior Validation Engineer

    2 days ago

    PSC Biotech Indianapolis, United States

    Job Description · Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to ...

  • Project Farma

    Validation Engineering Consultant

    2 days ago

    Project Farma Indianapolis, United States

    This role can involve up to 100% Travel · Why Precision for Medicine? · Welcome to the forefront of innovation in cutting edge patient treatments. We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science ...

  • Maxonic, Inc.

    Sr. Validation Engineer

    4 weeks ago

    Maxonic, Inc. Indianapolis, United States

    Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr. Validation Engineer. · Job Description: · Position: Sr. Validation Engineer · Location: Indianapolis, IN · Duration: 9+ months · Work Schedule: ONSITE ...

  • PSC Biotech

    Senior Validation Engineer

    2 weeks ago

    PSC Biotech Indianapolis, United States

    Job Description · PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to skyrocket our ...

  • The International Society for Pharmaceutical Engineering Inc

    Validation Engineer

    3 weeks ago

    The International Society for Pharmaceutical Engineering Inc Indianapolis, United States

    Position: · Validation Engineer (Pharmaceutical) · Location: · Indianapolis, IN · Duration: · 9 Months · Job Type: · Contract · Work Type: · Onsite · Shift: · Monday to Friday - 08:00 AM to 05:00 PM · Pay Rate: · 30-35/Hourly/W2 · Overview: · TekWissen Group is a workforc ...

  • Katalyst HealthCares & Life Sciences

    Validation Engineer

    2 weeks ago

    Katalyst HealthCares & Life Sciences Indianapolis, United States

    Responsibilities: · Determine project scope and strategy with client groups and other stakeholders to execute small and large capital projects in a cGMP environment. · Participate in the development of the following Validation efforts: Validation Planning, Protocol Generation, ...

  • Cardinal Health

    Sr. Quality Engineer, Validation

    1 week ago

    Cardinal Health Indianapolis, United States

    Anticipated salary range: $66,500 - $95,000 · Bonus eligible: No · Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. Medical, dental and vision coverage · Paid time off plan · Health savings account (HSA) · 401k saving ...

  • Cardinal Health

    Sr. Quality Engineer, Validation

    2 days ago

    Cardinal Health Indianapolis, United States

    **Anticipated salary range:** $66,500 - $95,000 · **Bonus eligible:** No · **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. · + Medical, dental and vision coverage · + Paid time off plan · + Health savings account ...

  • CAI

    Validation Engineer Senior 2

    1 week ago

    CAI Indianapolis, United States

    We are seeking CQV Engineers with 8-12 years' experience and we can assist with relocation costs. · Position Description: · The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing an ...

  • Yoh

    Sr. Process Validation Engineer

    3 weeks ago

    Yoh Indianapolis, United States

    Yoh is hiring a Sr. Process Validation Engineer for our well-established client in Indianapolois, IN. The mission with this client is to enable our customers to make the world healthier, cleaner, and safer. They run the world's largest clinical packaging operation and the clinica ...

  • Maxonic

    Sr. Validation Engineer

    4 weeks ago

    Maxonic Indianapolis, United States

    Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr. Validation Engineer. · Job Description: · Position: Sr. Validation Engineer · Location: Indianapolis, IN · Duration: 9+ months · Work Schedule: ONSITE ...

  • Maxonic

    Sr. Validation Engineer

    4 weeks ago

    Maxonic Indianapolis, United States

    Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr. Validation Engineer. · Job Description: · Position: Sr. Validation Engineer · Location: Indianapolis, IN · Duration: 9+ months · Work Schedule: ON ...

  • Maxonic

    Sr. Validation Engineer

    3 weeks ago

    Maxonic Indianapolis, United States

    Job Description · Job Description · Job description · Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a priorities · Position: Sr. Validation Engineer · Location: Indianapolis, IN · Duration: 9+ Months ( ...