- Provide technical guidance into the commissioning, qualification and start-up of various pharmaceutical / biopharmaceutical cGMP process equipment, utilities & facilities.
- Lead the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle
- Able to perform field execution of qualification test cases and protocols
- Support development of Project Validation Plans (PVPs) to ensure the action plan to test the system is applicable and relevant.
- Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met.
- Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following – Process equipment, clean utilities, automation systems, laboratory equipment, building & facilities
- Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
- Engage other departments, as required, into design reviews and decisions.
- Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).
- Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification and validation phases.
- Visit construction and installation sites, wearing necessary safety PPE.
- You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
- Supervise contractors during critical testing of system and equipment.
- Other duties as assigned by client, and/or MMR, based on workload and project requirements.
- As this position requires working on client sites, you will need to comply with the client's safety rules including mandatory vaccination policies for COVID-19, where applicable
- Lead/Mentor a team of validation engineers/specialists.
- 5+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
- Previous experience in the pharmaceutical / biotech industry, with knowledge of requirements for cGMP operations.
- Experience with commissioning & qualification of equipment & facilities is required.
- Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required.
- Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
- Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems are considered an asset.
- Experience with commissioning and qualification of biotech process equipment, such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF), CIP systems, Buffer systems, Clean Utilities would be an asset.
- Experience with Qualification or Validation of clean utilities and ISO clean rooms.
- Experience with preparation and execution of URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs
- Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset, but not required.
- Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
- Possess mentorship skills, to coach and develop junior and intermediate employees.
- Engineering degree, preferably in Mechanical, Electrical or Chemical.
- Travel may be required on occasion.
- Ability to handle multiple projects and work in a fast-paced environment.
- Strong multi-tasking skills
-
Validation Engineer
3 weeks ago
PSC Biotech Corporation Chicago, United States Full timeJob 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 ...
-
Validation Engineer
3 weeks ago
Katalyst Healthcares and Life Sciences Chicago, United StatesResponsibilities: Write and Develop Equipment/Facility/Utility and Instrument Qualification protocols (first in kind) and Validation/Qualification Policies. · Initiate an own Change Controls; provide validation assessments and remediation plans as required by the system/equipmen ...
-
Validation Engineer
2 weeks ago
Sterling Engineering Inc. North Chicago, United StatesJob Description · Job DescriptionJob Overview: · The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and u ...
-
Validation Engineer
2 weeks ago
AbbVie North Chicago, United StatesJob Description · Job DescriptionCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives acr ...
-
Validation Engineer
1 week ago
PSC Biotech Chicago, United StatesJob Description · 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 i ...
-
Validation Engineer
2 weeks ago
PSC Biotech Chicago, United StatesJob 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 ...
-
Validation Engineer
4 weeks ago
Colsh Consultants LLC. Chicago, United StatesStrongExperience in Computer Systems Validation (CSV) within the Pharmaceuticalindustry. · • Required Bachelor's degree in pharmaceutical Science OR related field of study. · •Schedule and plan equipment and process qualification workload to meet approvedschedules. · •Handle mult ...
-
Validation Engineer
2 days ago
AbbVie North Chicago, United States Full time· Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic ar ...
-
Pharmaceutical Validation Engineer
3 days ago
Ingredion Chicago, United StatesThis position is responsible for development, execution, & analysis of validation projects to demonstrate facility, equipment, and process consistency and cGMP compliance for an API facility. Responsibilities include the generation and execution of I Validation Engineer, Pharmace ...
-
Model Validation Engineer
1 week ago
Saxon Global Chicago, United StatesClient: One of the predominant US financial regulatory institutions · Title: Model Validation Engineer · Location: Hybrid Onsite (Chicago IL) 3 days/week Mandatory · Contract: 12 months · Target Rate: 85/hr C2C · Visa Status: USC, GC, H4 · Summary of 'Must Have' Skills: · ...
-
Lead Product Validation Engineer
2 weeks ago
Jabil Circuit, Inc. Chicago, United StatesJob Description · As a Lead, you own project validation will be able to technically lead the entire cross functional design team on their interactions and responsibilities for that project. A Lead Engineer is responsible for ensuring the phase gate technical milestones are met, i ...
-
PHARMACEUTICAL - Lead CQV / Validation Engineer
3 weeks ago
MMR Consulting Inc Chicago, United StatesJob Description · Job Description Salary: · Previous · Pharmaceutical/Biotech · experience is mandatory for this role. · MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in North America and globally. Its se ...
-
Sr. Validation Engineer
2 weeks ago
Mallinckrodt Pharmaceuticals Hobart, United States Full timeDescription · Summary of Position · Implements and executes validation projects including Equipment Validation, Packaging Validation, Computer System Validation, Data Integrity Assessments, and Cleaning Validation. Coordinates with cross-functional resources in the execution of ...
-
sr validation engineer
4 weeks ago
Fresenius Kabi USA, LLC Melrose Park, United StatesJob Summary Responsible for providing technical support to operations in terms of initial equipment/facility/utility qualifications and equipment/facility/utility requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance a ...
-
sr validation engineer
4 weeks ago
Fresenius Kabi Melrose Park, United StatesJob Summary · Responsible for providing technical support to operations in terms of initial · equipment/facility/utility · qualifications and · equipment/facility/utility · requalifications. Will participate in process and equipment improvement teams charged with enhancing t ...
-
Validation Engineer
4 weeks ago
Sterling Engineering Westchester, United StatesJob Description · Job Overview: · The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and updating old do ...
-
Validation Engineer
2 weeks ago
Sterling Engineering Westchester, United StatesJob Overview: · The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and updating old documentation to new ...
-
sr validation engineer
1 week ago
Randstad Morton Grove, United Statessr validation engineer. · morton grove , illinois · posted 7 days ago · job details · summary · $80,000 - $100,000 per year · permanent · bachelor degree · category life, physical, and social science occupations architecture and engineering occupations · reference48177 · j ...
-
sr validation engineer
1 week ago
Randstad Morton Grove, United Statessr validation engineer. · morton grove , illinois · posted 4 days ago · job details · summary · $80,000 - $100,000 per year · permanent · bachelor degree · category life, physical, and social science occupations architecture and engineering occupations · reference48177 · j ...
-
sr validation engineer
1 week ago
Randstad Morton Grove, United Statessr validation engineer. · morton grove , illinois · posted 5 days ago · job details · summary · $80,000 - $100,000 per year · permanent · bachelor degree · category life, physical, and social science occupations architecture and engineering occupations · reference48177 · j ...
PHARMACEUTICAL - Lead CQV / Validation Engineer - Chicago, United States - MMR Consulting
Description
Job Description
Job DescriptionSalary:Previous Pharmaceutical/Biotech experience is mandatory for this role.
MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in North America and globally. Its services include Engineering, Project Management, Validation and other Consulting services. MMR's Engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems and facilities. The work may require working out of client's facilities, which are typically in the Greater Chicago Area (within one hour driving distance of Chicago).
This role is primarily to be located in Bradley, Illinois.
Responsibilities
Qualifications
Send your resume to:
Equal Employment Opportunity and Reasonable Accommodations
MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.
.