Equipment Engineer

Katalyst Healthcares and Life Sciences

Summit, NJ

Job Summary:

The Equipment Engineer (Equipment Commissioning & Qualification - ECQ) supports the successful implementation, commissioning, qualification, and maintenance of equipment, instruments, facilities, and utilities in a GMP-regulated pharmaceutical environment.
The role is responsible for ensuring equipment remains in a commissioned, qualified, and validated state while supporting equipment implementation projects, qualification activities, compliance, and collaboration with internal teams and external service providers.

Roles & Responsibilities:

Maintain commissioned/qualified equipment, facilities, and utilities in compliance with policies, guidelines, and procedures.
Develop commissioning/qualification protocols and associated reports while adhering to change management processes.
Supervise vendors performing qualification activities.
Support the development of equipment operational procedures.
Support equipment validation activities and execute equipment qualification and validation protocols.
Develop validation and qualification deliverables, including Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary Reports.
Support the Change Management process.
Support equipment implementation projects, including scheduling, site preparation, installation, qualification, and turnover to business.
Support operation, calibration, and preventive maintenance of equipment to meet business requirements.
Complete qualification and validation documentation accurately and in compliance with client standards.
Review, prioritize, and respond to customer equipment qualification and support requests.
Provide technical support and guidance on equipment qualification issues.
Interface with customers to ensure expectations are met.
Provide technical support for equipment, utilities, facilities, and computerized systems qualification and validation issues.
Maintain positive working relationships with team members and site customers.
Ensure equipment, facilities, and programs remain compliant with regulatory requirements.
Participate in deviation investigations as a Subject Matter Expert (SME), when required.

Education & Experience:

BS in Engineering or Science related discipline preferred; equivalent relevant experience may be considered.
Minimum of 5 years of experience performing or supporting activities in a GMP environment.
Minimum of 3 years of experience in equipment, facilities, or utilities qualification.
Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, Computer System Validation (CSV) requirements, and Good Documentation Practices.
Knowledge of pharmaceutical manufacturing and laboratory systems.
Understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical environment.
Strong written, verbal, interpersonal, organizational, and multitasking skills.
Detail-oriented with a strong commitment to quality, safety, and compliance.
Ability to manage multiple projects and prioritize tasks effectively.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and database systems.
Experience with Electronic Data Management Systems such as ValGenesis is preferred.

Apply

Vacancy posted 3 days ago

Similar jobs that could be interesting for youBased on the Equipment Engineer in Summit, NJ vacancy

Equipment Engineer
...Position Summary The Equipment Engineer is responsible for supporting, maintaining, and improving semiconductor wafer fab equipment to ensure reliable manufacturing operations and consistent process performance. This role provides hands-on technical leadership in equipment...
Suggested
Full time
LigentCom Photonics
South Plainfield, NJ
4 days ago
Equipment Engineer
...Job Title BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent. 7 years of combined experience in FDA-regulated... .... Must have experience validating and using common lab equipment and stand-alone computerized lab systems. Must have experience...
Suggested
For contractors
Fortira
Warren, NJ
2 days ago
Sr Design Engineer
...Sr Design Engineer Bachelor's Degree in Engineering, preferably in Aerospace, Mechanical, or a related field A minimum of 10 years of experience in design engineering, preferably in the aerospace industry Proficiency in Solidworks, AutoCAD, and Inventor An...
Suggested
AVTC Group
Springfield, NJ
15 hours ago
Design Engineer
...Design Engineer Design and develop prototype models and methods to validate design concepts and final design including required supporting engineering calculations. Confer, work closely and obtain the necessary results with manufacturing, quality assurance, production...
Suggested
For contractors
AVTC Group
Springfield, NJ
15 hours ago
Product Engineer
...Product Engineer OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now...
Suggested
Local area
Flexible hours
Avantgarde
Madison, NJ
20 hours ago
Product Engineer
...SUMMARY: The Product Engineer focuses on project management - product development and product improvement activities within the Profit Center, ensuring efficient product substantiation, new product introduction, and on-going process improvements for assigned product...
Internship
Cincinnati Thermal Spray
Springfield, NJ
1 day ago
Senior Mechanical Design Engineer - Custom Automation & Robotics Systems
$80k - $140k
...Job Details: Senior Mechanical Design Engineer – Custom Automation & Robotics Systems Our client is a full-service systems integrator... ...machinery , robotic work cells, and special-purpose equipment from concept through final build Design automation systems...
Permanent employment
Flexible hours
Liberty Personnel Services, Inc.
Kenilworth, NJ
a month ago
Mechanical Engineer (Rotating Equipment)
...Rotating Equipment Engineer – Linden, NJ Seeking a Rotating Equipment Engineer to support operations and maintenance at a major chemical manufacturing facility in Linden, NJ . Provide engineering support for pumps, compressors, turbines, gearboxes, and other...
Full time
Allied Engineering and Design
Linden, NJ
2 days ago
Junior Process Engineer (2027 Grad)
...We are a specialized engineering company with international exposure and subject matter expertise in the design, fabrication and qualification... ...of sterile, high purity and potent containment process equipment and plants. We are growing our company size and capabilities through...
Full time
GMP Engineering Inc.
Rahway, NJ
1 day ago
Process Engineer
...laser wafer fabrication processes running smoothly, using various engineering means including SPC. Troubleshoot any issues occurring in... ...instructions and train production technicians Work with Equipment Engineers and help to maintain process equipment Develop metrology...
Full time
LigentCom Photonics
South Plainfield, NJ
2 days ago
H&H Design Engineer
$90k - $110k
...H&H Design Engineer Ranked the #4 Large Employer to Work for in America and residing in the Top 400 on Engineering News Record (ENR)'s List of Top Design Firms in the nation, TPD is currently hiring a Civil Engineer to serve as a H&H Study/Design Task Leader for Projects...
Currently hiring
Work at office
Immediate start
Traffic Planning & Design
Warren, NJ
5 days ago
Automation & Controls Engineer - Robotics
$80k - $135k
...Job Details: Automation & Controls Engineer - Robotics We are seeking an Automation & Controls Engineer – Robotics to design,... ...vision systems with PLCs, HMIs, robotics, and custom automation equipment Configure cameras, optics, lighting, and sensors to optimize...
Permanent employment
Flexible hours
Liberty Personnel Services, Inc.
Kenilworth, NJ
a month ago
Design Engineer
...Job Summary: Bergen Cable Technology Inc. is a privately held aerospace manufacturing company seeking a Design Engineer to support the engineering, manufacturing, and commercial teams. This position is responsible for translating customer requirements into manufacturable...
Bergen Cable Technology LLC
Fairfield, Essex County, NJ
4 days ago
Design Engineer
$45 - $49 per hour
DescriptionKforce has a client that is seeking a Design Engineer in Warren, MI.Summary:The main function of a Design Engineer is to develop... ...instruments, paints and brushes, or computer-aided design equipment* Modify and refine designs, using working models, to conform...
Kforce
Warren, NJ
2 days ago
Mechanical Engineer - MEP/HVAC, Rail & Transit, Vehicle Systems
$85k - $105k
...Mechanical Engineer - MEP/HVAC, Rail & Transit, Vehicle Systems | Woodbridge, NJ Location: Woodbridge, NJ | Full-Time | On-Site... ...design packages through submission Perform load calculations, equipment selection/sizing, and layout development Create and revise...
Full time
Work at office
Local area
Garg Consulting Services, Inc.
Woodbridge, NJ
2 days ago
Senior Mechanical HVAC Engineer
$110k - $140k
...Senior Mechanical HVAC Engineer Location US-PA-Bethlehem | US-PA-Reading | US-NJ-Parsippany-Troy Hills | US-PA-Wyomissing Job ID 7358 # Positions 1 Category Building Design Join Us: Finding a better way. At CHA...
CHA Consulting, Inc.
Parsippany, NJ
4 days ago
Plastics Process Molding Tooling Engineer
...related documentation. Supervise Molding Technicians and Process Engineers and assist Quality personnel with any process and/or... ...for new mold tooling and identify needed molding technologies (equipment/sensors) to advance capabilities. Requirements BSME or...
Full time
Temporary work
Work at office
Local area
Entegee
Fairfield, Essex County, NJ
4 days ago
Process Engineer
...Process Engineer Opportunity REAL Process Engineer who has legitimate experience with formulations of liquid suspensions and oral solid dosage processes? Seeking a TRUE PROCESS ENGINEER. MUST HAVE experience with formulations of liquid suspensions and oral solid dosage...
RIT Solutions
Morristown, NJ
18 hours ago
Senior Process Engineer
$115k - $130k
...Position: Senior Process Engineer Location: Parsippany, NJ Job Id: 2085-8104-27-NB # of Openings: 1 Elevate... ...environment. Participate in facility expansion, equipment installation, production infrastructure, and building-system projects...
Full time
Work at office
Local area
Immediate start
Flexible hours
Marotta Controls
Parsippany, NJ
2 days ago
Process Engineer
...About the job Process Engineer Job Title: Process Engineer Location: South Plainfield, NJ Company Overview Glint... ...data and prepare engineering reports Support process equipment maintenance and coordinate with suppliers Develop work instructions...
Glint Tech Solutions LLC
South Plainfield, NJ
3 days ago
Process Engineer
...efficiency, quality, throughput, and cost Develop and improve SOPs, controls, and standard work Partner with Electrical/Controls Engineering on process control improvements Investigate quality issues, customer complaints, and process deviations Support capital...
T. Burks & Associates
Newark, NJ
4 days ago
Principal Process Engineer
...Job Summary: Take lead on various engineering efforts in an advanced InP BH laser fab, including process development, yield improvement... ...production. Investigate root cause and develop solutions. Work with equipment team and help maintain process equipment. Participate in new...
Full time
LigentCom Photonics
South Plainfield, NJ
7 hours ago
Process Engineer
...product formulations, scale-up activity, process validation, equipment qualification, process related technical issues and investigations... ...FDA. Requirements: Bachelor of Science, Pharmacy, Engineering, or Chemistry. 8 to 10+ years in Pharmaceutical...
Contract work
For contractors
Katalyst Healthcares and Life Sciences
Morristown, NJ
3 days ago
Senior Process Engineer
...Job Description Position: Senior Process Engineer Location: Tulsa, OK | Riverton, WY | Cairo, OH | Beaumont, TX | Anacortes,... ...experience in process design — PFDs, P&IDs, mass/energy balances, and equipment specifications · Proven ability to scope and lead...
For contractors
Work experience placement
H1b
Work at office
Remote work
Visa sponsorship
Chemtrade Logistics
Parsippany Troy Hills, NJ
4 days ago
Senior Product Security Engineer
...to drive a Secure by Design culture within our Breast & Skeletal Health Connected Health products. As a Senior Product Security Engineer , you will play a pivotal role in ensuring the security and integrity of our innovative healthcare solutions. If you are passionate...
Remote work
Hologic
Newark, NJ
1 day ago
Industrial Sales Engineer (Power Generation Equipment)
$85k - $130k
...Description Kinsley Power Systems is seeking an Industrial Sales Engineer to add to their team! The Industrial Sales Engineer's main... ...sell industrial power generation applications including related equipment (transfer switches, switchgear, load banks, fuel tanks, etc.)...
Contract work
For contractors
Work at office
Flexible hours
Night shift
Kinsley Group
Newark, NJ
12 days ago
Design Quality Engineer
...Summary: Our client is a medical device manufacturer seeking a Design Quality Engineer to support FDA remediation activities across design controls, product risk management, and quality system gaps. This individual will partner with Quality, R&D, Regulatory, and...
Katalyst Healthcares and Life Sciences
South Plainfield, NJ
3 days ago
Industrial Controls Engineer
...Job Purpose The Industrial Engineer role is primarily responsible for company-wide continuous improvement initiatives. Key Responsibilities... ...automated alarming systems notifying the plant of down equipment. Design, construct and install automation devices....
Full time
Ring Container Technologies
Springfield, NJ
1 day ago
Senior Mechanical Engineer
...CMTA, a Legence company CMTA ( is one of the fastest growing engineering firms in the U.S., with nationally recognized expertise in sustainable, high-performance building engineering. We are a collaborative, innovative, and energetic team that leverages a data-driven...
For contractors
Work at office
Local area
Immediate start
Flexible hours
CMTA Inc
Madison, NJ
4 days ago
Mechanical Design Engineer
$100k - $120k
...Mechanical Design Engineer Perform engineering valve design functions for the development of new products and for the modification of existing products. Design and develop prototype models and methods to validate design concepts. Collaborate with team members...
For contractors
AVTC Group
Springfield, NJ
4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Equipment Engineer. Be the first to apply!