Validation Engineer

Katalyst Healthcares and Life Sciences

Enola, PA

Responsibilities:

Client is seeking validation consultants to support a 9-month minimum onsite project in South Carolina. The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment qualification.
The project is being driven by audit findings and identified gaps in the site's validation program. The primary focus will be equipment validation, especially around tanks used for drug substance mixing and drug product filling. The team needs to assess whether existing IOQ/OQ documentation is robust enough, identify gaps between OQ and PQ, and determine whether current qualifications can support performance qualification expectations.
The consultants will also support product-specific mixing study needs, including evaluating mixing from an equipment qualification perspective. This includes understanding tank qualification, viscosity considerations, matrix/bracketing approaches, risk assessment, and how to identify, group, and mitigate validation gaps.
The team will also support smoke study execution in an aseptic processing environment. The site has a tunnel and two lyophilizers, so candidates should understand aseptic technique, equipment operation, and how to drive execution as a validation representative.
This role is execution-heavy, but the client also needs consultants who can perform gap assessments and provide guidance on validation strategies. The lead consultant should be able to drive the project, guide internal resources, manage execution, and keep the validation effort moving forward.

Requirements:

Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred. Equivalent hands-on validation experience can be considered.
Include Must Have:
Validation execution experience in a pharmaceutical, biotech, or aseptic manufacturing environment.
Equipment qualification experience.
Strong understanding of IOQ/OQ/PQ expectations.
bility to perform gap assessments.
Tank qualification experience.
Mixing study experience or strong understanding of equipment-based mixing qualification.
septic processing experience.
Smoke study experience or strong understanding of smoke study execution.
bility to support protocol execution and documentation.
bility to assess whether qualification packages are robust enough.
bility to identify validation gaps and recommend mitigation strategies.
bility to handle a strong personality and drive work forward without being timid.

Apply

Vacancy posted 4 days ago

Similar jobs that could be interesting for youBased on the Validation Engineer in Enola, PA vacancy

Validation Engineer
...Validation Consultant Client is seeking validation consultants to support a 9-month minimum onsite project in South Carolina. The... ...the validation effort moving forward. Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred...
Suggested
Katalyst HealthCares & Life Sciences
Harrisburg, PA
1 day ago
Validation Engineer
...small teams in document development and/or execution Qualifications and Experience - Bachelor’s degree in a science or engineering field (or equivalent experience) - 2–4 years’ experience in commissioning and qualification in a regulated industry -...
Suggested
Worldwide
CAI
Harrisburg, PA
29 days ago
Propulsion System Validation Engineer
...identify software defects in electrified and internal combustion engine (ICE) powertrains, ensuring the delivery of robust, high-... ...learning and problem-solving. This role is responsible for the validation of production powertrain control modules, including hardware, software...
Suggested
Full time
Immediate start
Stellantis
Harrisburg, PA
5 hours ago
Senior Validation Engineer
...Execution & Safety - Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety - Deliver C&... ...and Experience - Bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute...
Suggested
For contractors
Worldwide
CAI
Harrisburg, PA
24 days ago
VP, Manufacturing & Engineering Transformation
...The VP, AI & Digital Thread Solutions at Eaton is a board-visible enterprise transformation leader accountable for connecting engineering, supply chain, manufacturing, and service through an integrated data and AI backbone that drives measurable business outcomes. This...
Suggested
For contractors
Relocation package
Eaton Plc
Harrisburg, PA
3 days ago
Mgr, Energy Efficiency Engineering
$155.7k - $173k
.... Primary Purpose of Position The Manager, Development Engineering is responsible for hands-on leadership of the Development Engineering... ...a focus on cost-effective outcomes Must have and maintain a valid driver's license Must have the ability to speak, read and...
Constellation Energy
Harrisburg, PA
5 days ago
Industrial Engineering M
...operations and driving measurable performance gains? As an Industrial Engineer , you'll play a pivotal role in shaping the future of our... ..., supporting business case development, productivity validation, and capital planning. Maintain strong partnerships with external...
Seasonal work
Distribution & Transportation
Harrisburg, PA
4 days ago
Launch Industrial Engineer
...General Assembly Launch Industrial Engineer - Working along with Workstation Designers to design workstations which are friendly to operators on the shop floors so that they can produce quality vehicles in the most efficient way. Collaborate with cross functional teams...
Full time
Immediate start
Stellantis
Harrisburg, PA
3 days ago
Senior Power System Engineer
$134.26k
...and construction projects that impact our world? CDM Smith offers employees opportunities to delve into many aspects of electrical engineering, including the design of complex power systems, observation and construction services, and power system analyses, etc. We want to...
Full time
H1b
Work at office
Relocation package
Flexible hours
CDM Smith
Harrisburg, PA
1 day ago
Senior Power Systems Studies Engineer
$97.5k - $199.5k
...Job Description Senior Power Systems Studies Engineer Role Summary We are seeking a Senior Power Systems Studies Engineer to... ...state, dynamic, and power quality studies, as well as developing validated simulation models Key Responsibilities ~ Lead EMT, steady...
Temporary work
Flexible hours
Oracle
Harrisburg, PA
4 days ago
Automation Engineering M
$70k - $110k
...Automation Engineer Harrisburg Engineering Center (HPEC) - Harrisburg, PA 17111 Salary Range $70,000.00 - $110,000.00 Salary Job Shift First Shift Description Assist with the design, development, and building of automated assembly machines. Essential Duties...
Shift work
Day shift
JST GROUP
Harrisburg, PA
1 day ago
Principal Power Systems Engineer
$139.4k - $291.8k
...highly complex component issues. Implements enterprise-level validation strategies, ensuring electrical system performance, reliability... ...and regulatory standards. -Leads complex sustaining engineering activities, resolving customer escalations, performing root...
Temporary work
Flexible hours
Shift work
Oracle
Harrisburg, PA
2 days ago
Digital Payment Processing Developer
...tools (Prometheus, Grafana). Exposure to infrastructure-as-code (Terraform, Helm). Background in DevOps or Site Reliability Engineering. Prior experience with PTC tolling solutions is highly desired. Solid understanding of tolling industry standards,...
Work at office
Remote work
Work from home
Flexible hours
S R INTERNATIONAL INC
Harrisburg, PA
13 days ago
Electronics Engineer (Industrial Controls)
...Telework Eligible Yes Major Duties As an Electronics Engineer (Industrial Controls) you will be responsible for the following duties (If selected at the GS-07/09/11 level, duties will be performed in a developmental capacity): Provides engineering support and...
Full time
Internship
Remote work
Defense Logistics Agency
New Cumberland, PA
2 days ago
Distribution Engineering Tech - REMOTE
$59.15k - $106.93k
...thrive, professionally and personally. For us, helping you grow your career is good business. Leidos is seeking Distribution Engineers & Designers in the Eastern , PA region who are passionate about electric utility design engineering. We’re looking for...
Work at office
Local area
Immediate start
Remote work
Flexible hours
Leidos
Harrisburg, PA
5 hours ago
App Packaging Specialist
$103k - $123k
...automation test frameworks/solutions. Acts as a lead to a team of engineers developing and maintaining application software and database... ...end to end application inventory, analysis, packaging, and validation using MSIX, Win32, Intune wrapping, and mobile app format....
Contract work
Work at office
ASM Research, An Accenture Federal Services Company
Harrisburg, PA
8 days ago
Senior Distribution Engineer
$73.45k - $132.78k
...professionally and personally. For us, helping you grow your career is good business. Leidos is seeking a Senior Distribution Engineer in the Allentown, PA area who is passionate about electric utility design engineering. We’re looking for someone who is...
Work at office
Local area
Immediate start
Remote work
Flexible hours
Leidos
Harrisburg, PA
5 hours ago
Highway Safety & Traffic Operations Engineering Intern (College)
$21.23 - $22.13 per hour
...Employment Program! This internship position is situated within the Highway Safety Section, specifically focusing on the Safety Engineering and Risk Management Unit. This unique internship opportunity allows students to engage in a variety of projects across multiple disciplines...
Hourly pay
Full time
Part time
Summer work
Internship
Work at office
Local area
Remote work
Commonwealth of Pennsylvania
Harrisburg, PA
3 days ago
NOC / Senior Operations Management Center Engineer - Data Center Facilities - MI
$109.2k - $223.4k
...planned changes, service impacts, and maintenance windows. Validate start and stop of planned work activities and confirm completion... ...teams during time-sensitive operational events. ~ Degree in Engineering, Facilities Management, Operations, or related field preferred...
Temporary work
Work at office
Flexible hours
Night shift
Oracle
Harrisburg, PA
7 days ago
Nuclear Engineer
...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...
Apprenticeship
Work at office
US Navy
Hampden, PA
5 hours ago
Building Automation Advanced Field Service Engineer - Raleigh, NC
...As an Advanced Field Service Engineer - Building Automation at Honeywell, you'll be at the forefront of delivering smarter, safer, and... ...computers, and networking ~ High school diploma or equivalent ~ Valid driver's license with acceptable driving record WE VALUE...
Temporary work
For contractors
For subcontractor
Work at office
Flexible hours
Night shift
Honeywell
Harrisburg, PA
5 days ago
Global Safety & Compliance Engineer - High-Power Systems
$80k - $110k
...Job Signal & Strand is partnering with a leading global manufacturer in the power and interconnect space to hire a Safety Agency Engineer. This role serves as the central authority for global compliance, ensuring products meet international safety standards and achieve...
Contract work
Local area
Worldwide
Flexible hours
Signal and Strand
Harrisburg, PA
21 days ago
Distribution Engineer, Electrical Utility
$73.45k - $132.78k
...professionally and personally. For us, helping you grow your career is good business. Leidos is seeking a Senior Distribution Engineer in the Allentown, PA area who is passionate about electric utility design engineering. We’re looking for someone who is...
Work at office
Local area
Immediate start
Remote work
Flexible hours
Leidos
Harrisburg, PA
5 hours ago
Lead Instrumentation & Controls Engineer 1 - Nuclear
$118.02k - $180.31k
...). This is expanding work in the Instrumentation and Controls Engineering group. You will work on major process controls engineering projects... ...preparation, Attend client meetings and site walkdowns to validate scope and ensure client satisfaction Support station outage...
Hourly pay
Contract work
Local area
Worldwide
Flexible hours
Sargent & Lundy
Harrisburg, PA
3 days ago
Power Integrity Engineer
...business equipment, and automotive. Position: Power Integrity Engineer Location: Valley Green, PA Amphenol High Speed Products... ...optimize power and signal integrity. Develop PDN models and validate through lab measurements (VNA impedance sweeps, oscilloscope ripple...
Amphenol TCS
Yocumtown, PA
11 days ago
CQV Engineer
...Job Description: We are looking for CQV Engineers / System Owners to take ownership of specific process and utility systems within... ...00 methodology. Ensure systems are ready for handover to validation/operations. Requirements: 4-7 years' experience within...
Katalyst Healthcares and Life Sciences
Harrisburg, PA
3 days ago
Imaging Engineer II
...national level Annual Merit Increases Summary The Imaging Engineer II installs, inspects, troubleshoots, repairs, calibrates, and... ...move up to 50 lbs while working with medical equipment Valid drivers license required; variable travel requirements depending...
For subcontractor
Work at office
TriMedx
Harrisburg, PA
4 days ago
Presales Engineer -BFSI - ML/AI
...acquisition of Mendix in 2018, Siemens Digital Industries Software is driving transformation to enhance the digital enterprise where engineering, manufacturing and electronics meet the future of innovation. Mendix employees have the opportunity to work in a hyper-growth...
Local area
Siemens
Harrisburg, PA
14 days ago
PKI Engineer, Mid
...The PKI Engineer, Mid designs, implements, and maintains enterprise public key infrastructure services that underpin secure authentication... ...(for example, CISSP or PKI-specific credentials) that validate expertise in cryptography and certificate management. Experience...
Contract work
Work at office
ASM Research, An Accenture Federal Services Company
Harrisburg, PA
1 day ago
VMWare Visualization Engineer
...Job Description: Position Summary: The Virtualization Engineer is responsible for the architecture, implementation, optimization, and lifecycle management of the enterprise VMware virtualization environment. This role serves as a subject matter expert across the...
Prequel Solutions
Harrisburg, PA
2 days ago

Do you want to receive more vacancies?

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