Process Engineer - Lyophilization & Isolator Systems
Stark Pharma Solutions Inc
Position: Process Engineer - Lyophilization & Isolator Systems
Location: West Point, PA
Duration: Long Term
Job Overview
We are seeking an experienced Process Engineer to support the startup and commissioning of a new GMP manufacturing facility. The ideal candidate will provide technical oversight for lyophilization and isolator systems while working closely with Engineering, CQV, and Operations teams to ensure successful equipment installation, startup, commissioning, and GMP readiness.
Key Responsibilities
- Provide technical support for the installation, startup, and commissioning of lyophilizers, isolators, and associated aseptic process equipment.
- Collaborate with CQV teams to support commissioning, qualification, and equipment turnover activities.
- Coordinate with vendors, contractors, and cross-functional teams throughout project execution.
- Support Process Hazard Analyses (PHAs) and ensure equipment is implemented in accordance with GMP and site safety requirements.
- Troubleshoot equipment issues during startup and support operational readiness.
- Ensure compliance with GMP requirements throughout equipment startup and commissioning.
- Assist with engineering documentation and process improvement activities.
Required Qualifications
- Bachelor's degree in Engineering or a related technical discipline.
- Minimum 5 years of engineering experience in pharmaceutical or biotech manufacturing.
- Hands-on experience with lyophilization (freeze dryers), isolator systems, or aseptic processing equipment.
- Experience supporting GMP equipment startup, commissioning, and qualification activities.
- Familiarity with CQV (Commissioning, Qualification & Validation) processes.
- Experience supporting facility startups, equipment installation, and commissioning projects.
- Knowledge of sterile pharmaceutical manufacturing and GMP regulations.
- Experience participating in Process Hazard Analyses (PHAs) is preferred.
- Strong communication, troubleshooting, and cross-functional collaboration skills.
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Process Engineer - Lyophilization & Isolator Systems in West Point, PA vacancy
- ...Job Description Job Description Job Title: Process & Systems Engineer Reports To: Engineering Manager FLSA Status: Exempt, Full-Time Summary: The Process & Systems Engineer designs, develops, and maintains systems that support production, operations...SuggestedFull timeWork at office
- Brief Job Description The Process Engineer role focuses on the following accountabilities: Troubleshooting and Problem-Solving - Ability to... ...transfer, and mass transfer. Familiarity with process control systems, automation and PLC programming and implementation in...Suggested
$132.38k - $220.63k
...WJE) is seeking an Associate Principal or Principal Electrical Engineer to be an integral part of expanding our electrical engineering... ...electrical infrastructure. Project scopes range from new design and system specification to in-situ evaluation and problem-solving to...SuggestedFull timeFor contractorsWork at officeWorldwide$97.7k - $160k
Schweitzer Engineering Laboratories (SEL) is looking for someone to join our Sales & Customer Service team as a Power System Metering Engineer in our Northeast region. If you have strong knowledge of electric power systems, revenue metering, power quality, and metering...SuggestedFull timeApprenticeshipFlexible hours$84.2k - $160k
As a Network Engineer - Power Systems (OT), you will be responsible for providing expert technical support and power system automation solutions. Your role will involve teaching, advising, and supporting customers to ensure the reliability and safety of power grids.At...SuggestedFull timeApprenticeshipWork experience placementFlexible hours- This is for an Electrical Systems Engineer position in the Engineering department of the AMETEK PDS Electrical Power Distribution team. As... ..., implementation and monitoring of requirements management processes, tools, risk, issues, opportunity management and technology...Work experience placementWork at office
- Sr Lab System Support Engineer 5 months West Point, PA - onsite No OTJob Description/ Responsibilities Job Summary Sr Lab System Support Engineer... ...2. Lab system vendor handling 3. Lab system business processes understanding in pharmaceutical regulatory environment Roles...
- ...consulting services, rocket and balloon systems, flight test services, satellite propulsion... ...the customers satellites. As a Systems Engineer, you will perform multi-domain technical... ...documentation and follow formal processes required in the Space business. Bachelor...Permanent employmentFull timeTemporary workWork at officeLocal areaImmediate startFlexible hours3 days per week
SSC - Swedish Space Corporation
Spring House, PA2 days ago $65 per hour
...Overview: We are seeking a well-rounded Senior Virtualization & Systems Engineer who is equally comfortable building new infrastructure from... ...any accommodations or adjustments throughout the interview process and beyond, please let us know. We celebrate our inclusive...Full time- At Kulicke and Soffa, (NASDAQ:KLIC) our engineers make that decision daily. We are an international... ...concepts into actual parts of the system, and testing the developed module, the... ...linear regression analysis, statistical process and control.Analysis of situation or...
- ...DescriptionWe have an exciting opportunity for a Laboratory Operations Engineer to join a growing team at a PSS Client site. The Laboratory Operations Engineer will be responsible for supporting process systems in clinical and non-clinical Regulated Bioanalytics laboratories....Full timeContract workLocal areaMonday to Friday
- As Principal Engineer you will be involved from proof of concept to mass production readiness... ...able to define the architecture of the system concepts based on the core starting... ...complex framework, system or product• Defines processes for technical platforms, system...Flexible hours
$86k - $138k
ResponsibilitiesWe are seeking a motivated product quality SYSTEM ENGINEER to support the planning, test development, data definition, and... ...Knowledge of sensor imaging systems, products, and exploitation processes Knowledge of image product tasking, collection, processing,...Contract workRemote workShift work- ...solutions to some of the worlds’ hardest engineering problems. Our culture encourages... ...area is seeking a talented and dedicated Systems Engineer-IT to become a member of an Agile... ...Linux System Administration• Agile/Kanban process• Security+ or CISSP certification• Active...Full timeWork at officeRemote workFlexible hours
- ...create, design, and build solutions to some of the worlds’ hardest engineering problems. Our culture encourages employees to dream big,... ...better tomorrow with you.You will be responsible for developing system level artifacts and engaging with customers, mission partners,...Full timeFor contractorsWork at officeRemote workFlexible hours
$87.1k - $157.45k
...business.Your greatest work is ahead!Leidos Defense Systems is seeking a skilled Digital Systems Engineer who loves collaboration and being a part of... ...Familiarity with DoD acquisition lifecycle and program processes• Experience applying parametric cost modeling, Monte...Full timeContract workWorldwide$71.6k - $119.4k
...information, please visit .About the RoleReed Tech is seeking a Systems Engineer III responsible for the design, implementation,... ...patching, configuration management, and compliance validation processes using PowerShell, Ansible, Terraform, or similar automation...Full timeLocal areaImmediate startWorldwideFlexible hours$89.3k - $157.55k
...Missile.Lockheed Martin (LM) is looking for a resourceful Senior Systems Engineer to become a member of the Systems Engineering and... ...requiredDesired Skills:• Knowledge in Systems Engineering concepts and processes• Writing requirements documentation and coordinating...Full timeTemporary workWork experience placementWork at officeRemote workFlexible hours- ...part of Lockheed Martin Rotary & Mission Systems business area, our team supports... ...including networking infrastructure and process management, in addition to Tactical Command... ...across the globe.THE WORKAs a IT- Systems Engineer Sr. on the TTWCS Program , you will:• Lead...Full timeWork at officeRemote workFlexible hours
- Provide direct engineering and technical support of site operating technology (OT) networks and systems. Evaluate and develop technology, plan and implement modifications, maximize... ...administration, maintenance and upkeep of process control systems.OR in lieu of education 3+...Full timeLocal area
- ...invite you to join Lockheed Martin Rotary and Missions Systems (RMS) as a Systems Engineer!Lockheed Martin is a global leader in aerospace, defense... ...specific weekly schedule will be discussed during the hiring process.Work Schedules: Lockheed Martin supports a variety of...Part timeWork at officeRemote workFlexible hours
- ...the Fishhooks program, you will be responsible for developing system level artifacts and engaging with customers, mission partners,... ...customer relationship from the ground up.As a member of the Systems Engineering team you will:• Perform in an accelerated, collaborative,...Full timeFor contractorsInterim roleWork at officeRemote workFlexible hours
$87.1k - $157.45k
...community. Our Mission, Vision, and Values guide the way we do business.Your greatest work is ahead!Leidos Defense Systems is seeking a skilled Digital Systems Engineer who loves collaboration and being a part of something big, to join our team. As a Leidos Digital Systems...Full timeWorldwide- ...SUMMARY Supportsmanufacturing, quality, and process improvement activities for the SEQ businessunit. Works closely with Engineering and Operations to improve safety, quality,... ...equipment, instrumentation, or fluid systems 4-6 years Preferred 7-9 years...Work experience placement
Matheson Tri-Gas
Montgomeryville, PA1 day ago $123k - $139k
...Job Description Job Description Technical Sales Engineer - Encoder Systems Location: Blue Bell, PA Salary Range: $ 123,000.00 to $ 139,000.00 About SKF: SKF, reducing friction since 1907, re-imagining rotation for a better tomorrow! SKF is an industry...Temporary workWork from homeFlexible hours$112k - $179k
ResponsibilitiesWe are seeking a motivated product quality SYSTEM ENGINEER to support the planning, test development, data definition, and... ...for example EO/IR/SAR)Knowledge of NSG tasking, collection, processing, exploitation and dissemination (TCPED) image...Contract workRemote workShift work$145.6k - $218.4k
...days per week, with one remote day. Five days onsite may be required based on business needs.About the RoleThe Principal Engineer, Platform Systems is a hands-on technical leader on the Product Engineering Architecture team. This role provides design leadership, cross-...Temporary workWork at officeRemote workShift work$82k - $140k
...We are seeking a skilled and dedicated Power System Protection Engineer to join our Engineering Services team. As a Power System Protection Engineer, you will be responsible for ensuring the reliable and secure operation of power systems by designing, testing, implementing...Full timeApprenticeshipWorldwideFlexible hours- ...MartinDescription:WHO WE ARE:Lockheed Martin Rotary and Mission Systems has an opportunity for a Systems Engineering Integration and Test (SEIT) Lead for operational... ...for upgrades, and oversee the change management process including chairing engineering review boards. The...Full timeWork at officeRemote workFlexible hours
- ...Lockheed Martin Space is seeking a Systems Engineer-IT to join an Agile team focused on IT Infrastructure, including Systems Administration, Networking and Hardware, in the Whiskey Program Area. The role involves Windows/Linux administration, automation scripting, patch...
Lockheed Martin Corporation
King of Prussia, PA5 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Process Engineer - Lyophilization & Isolator Systems. Be the first to apply!
