Engineering Jobs in Lansdale

55 positions found — Page 2

Logistics Planner
Salary not disclosed
Lansdale, PA 2 days ago

Logistics Planner Specialist II

Location(s): West Point, PA; Rahway, NJ

Work Environment: Hybrid


Job Summary:

The Logistics Planner Specialist II is responsible for driving tasks to completion and mentoring junior staff. This role requires a heightened level of autonomy and strong business acumen. The Logistics Planning Specialist will be responsible for supporting and work cross-functionally with, but not limited to, Clinical Supply Planning, Country Clinical Operations, CMOs/CROs, Distribution, Regulatory, External Operations Management, Operational Expense Management, Trade Operations, and Trade Compliance to support and plan distribution for Clinical Trial Material utilizing approved depot networks. Act as the Logistics Planner and develop distribution plans and execute activities for network preparedness of distribution activities. Communicate with all constituents and be the advocate for the distribution strategy for clinical trials. In addition to typical distribution planning activities, the individual will also be responsible for alignment of the lead-time and routing in SAP, and cost analysis for distribution network selection. Collaborate across functions and contribute to cross-functional initiatives, and, where appropriate, assume leadership of low-to-moderate complexity projects to drive defined outcomes.

Key Responsibilities:

  • Drive tasks to completion amidst ambiguity.
  • Mentor junior staff and provide guidance on project management.
  • Collaborate across functions to achieve business objectives.
  • Ownership of SAP-related processes that Logistics Planning is accountable
  • Project Contributor, and at times lead, for both internal and cross-functional projects
  • Proficient in cGMP
  • Ability to function in a team environment and pursue information when it is not readily available.
  • Communicate with all constituents and be the advocate for the clinical trial distribution strategy
  • Partner with Clinical Supply Planning and Distribution Centers to oversee and implement distribution planning documents for clinical study protocols
  • Represent Logistics Planning at internal communication meetings
  • Serve as the functional area expert on country shipping and trade compliance, distribution routes, country and global distribution challenges
  • Adherence to regulatory, global and site policies and procedures governing operations activities are critical.

Qualifications:

  • Bachelor's degree preferred; candidates with relevant experience may be considered.
  • 3+ years of experience in a related field; candidates without a degree should have 6+ years of relevant experience.

General Skills:

  • Strong communication and proficient project management skills.
  • Ability to collaborate across functions and teams.
  • Analytical thinking and problem-solving skills.
  • Detail-oriented with the ability to prioritize tasks effectively.

Unique Responsibilities:

  • Ability to make connections at a higher level within the function.
  • Self-motivated with the ability to mentor others.
Not Specified
Metrology Specialist
🏢 Kelly Science, Engineering, Technology & Telecom
Salary not disclosed
Lansdale, PA 2 days ago

Metrology Specialist I

On-site in West Point PA

Summary:

  • Manage equipment assets at multiple locations
  • Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or communicate with the vendor/ service engineer to identify resolutions
  • Participate in computer system validation activities associated with new or upgraded equipment or software packages.
  • Originate and progress Deviations and Change Control records
  • Perform and document investigations and assist in developing and implementing CAPA plans
  • Contribute to new SOP drafting, implementation, and revisions.
  • Represent the laboratory on all aspects of laboratory equipment during audits.
  • Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures.
  • Customer focused mindset with the ability to communicate adequately (verbally/writing) to all levels within the organization.
  • Willingness and ability to quickly upskill in Merck Facilities/Instrument support programs SAP, ProCal, BAS, LAMP, Electronic Validation, and other document and/or asset repositories
  • Initiate, process and track work orders to facilitate timely repairs, modifications and moves of laboratory equipment.

Calibration Focus:

  • Prepare, review, and approve archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installation & operational qualification documentation, and calibration documentation.
  • Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships.
  • Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support.


Support the purchase, installation, and equipment qualification of new laboratory equipment.

*** There will be training opportunities to support Validation*** Validation activities are included below

  • Support primarily the qualification/validation of computerized analytical systems as per current guidelines.
  • Partner with the business unit in the laboratories, various quality support oversight, IT technical support, and various software and instrument vendors/manufacturers.
  • Perform any required change control during the life cycle of a computerized system.
  • Decommission systems as required as part of the equipment qualification/validation life cycle.
  • Manage the capital purchasing and initial installation of computerized analytical systems prior to validation.
  • Participate in various data integrity and lab modernization activities as required.
  • Will possess direct experience operating analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large molecule focus).
  • Will have the ability to thoroughly review and scrutinize validation requirements through the life cycle of the system.

General Requirements Level 1:

-Bachelor’s degree in biological or chemical science and/or engineering plus

-2-4 years of experience participating in the validation of computerized laboratory systems or instruments (e.g. system Installation and Operational qualification, Performance qualification

-Experience working in a GMP environment and maintaining laboratory equipment.

-Highly organized, strong communication skills.

-Capable of working independently.

-Solutions orientated mindset with the ability to handle multiple high priority tasks at one time.

-Ability to succeed in a dynamic environment; flexibility to respond to changing priorities.

-Awareness to independently prioritize tasks and responsibilities based on actual or perceived level of importance and/or potential impact to the GMP environment.

Not Specified
Validation Scientist
Salary not disclosed
Sellersville, PA 2 days ago

JOB OVERVIEW:

The Validation Scientist position encompasses all areas of Technical Services with primary focus on technology transfer, scale-up, process optimization, process/packaging validation, commercial production technical support as well as equipment qualification and cleaning validation support.


KEY ROLES/RESPONSIBILITIES:

  • Lead and execute projects such as technology transfer, scale-up, process optimization process/packaging validation as well as equipment qualification and cleaning validation support to meet critical project deadlines.
  • Provide technical support in the investigation of manufacturing incidents and major deviations. Assure thoroughness of investigation and documentation as well as implementation of preventive/corrective actions as necessary.
  • Conduct commercial production technical support activities such as qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, process parameters, yield limits, hold time studies, etc.
  • Execute utility and process equipment qualification support activities such as installation, operational and performance qualifications, periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, etc.
  • Perform cleaning validation support activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, maintain cross contamination program, etc.
  • Develop and/or execute experimental designs and approaches to resolve technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques.
  • Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, regulatory submissions, master batch records, change control, etc.
  • Complete and document physical sampling and testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness and friability; sample for analytical and microbiological testing.
  • Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.
  • Represent Technical Services at project team meetings and provide sound technical advice.
  • Coordinate and interface with Operations, Facility Engineering, Quality Control, Quality Assurance and Regulatory Affairs groups to assure successful project execution.
  • Directly interact with Piramal Pharma Solutions clients.
  • Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.


EXPERIENCE:

  • Minimum of a Bachelor's degree in a scientific discipline (e.g., Chemical Engineering, Pharmaceutics, Pharmacy, Chemistry or equivalent) with a minimum of 3 years experience in Technical Services, Process Engineering, Process Validation, Formulation or related field in the pharmaceutical industry.
  • Experience in laboratory and production scale manufacture of solid oral, liquid and semi-solid dosage forms using equipment such as comminuting mills, high-shear granulators, fluid bed dryers, blenders, tablet presses, tablet film coaters, encapsulates, low and high-shear mixing vessels, homogenizers, pumps, packaging, etc.
  • Working knowledge of cGMP (Current Good Manufacturing Practices) regulations, SUPAC guidance, and general compliance expectations.
  • Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment impact evaluation, and technical report writing.
  • Must possess research and problem solving abilities and be capable of producing detailed documentation, understand and make generalized and specific conclusions from project data.
  • Technical writing experience is required with attention to detail skills essential.
  • Must be able to work in a team environment with effective project planning/management, analytical thinking, organization, and execution skills.
  • Must have proficiency in the Microsoft Office Suite programs.
  • Demonstrated professionalism and excellent communication skills with internal and external personnel are essential.
  • Ability to work effectively managing multi projects at a fast pace withcross-functional departments and manage priorities to meet timelines.
  • Must be innovative, proactive, resourceful and committed to continuous improvement.
  • Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.


WORK ENVIRONMENT:

The position requires the ability to work in ahigh demand office and manufacturing setting with time spent performing "on the floor" activities in laboratory and manufacturing areas. The position may require extended hours including evenings and weekends as well as work hours on 2nd and 3rd shifts depending on project needs.

Not Specified
Quality Assurance Specialist (3rd Shift)
Salary not disclosed
Fort Washington, PA 2 days ago

Job Details:


Global Pharmaceutical Company

QA Shop Floor - 3rd Shift

Fort Washington, PA - Onsite

Long Term, Ongoing Contract

Pay rate $25-30/hr


QA Shop Floor - 3rd shift

Must be able to work four 10 hour days, Sun to Wed 9:30pmEST to 8:00AMEST or

Wed to Sat: 9:30pmEST to 8:00AMEST


Responsible for maintaining quality records, assisting with corrective action plans, and supporting quality system improvements. You will collect and organize data, prepare reports, and ensure inspection readiness while addressing routine quality inquiries.


Key Responsibilities

Collaborate with cross-functional teams to implement innovative quality assurance protocols on the shop floor, ensuring seamless production flow and minimal defects.

Utilize data-driven insights to proactively identify potential quality issues and develop creative solutions to enhance product reliability.

Engage in hands-on inspection of products, applying a keen eye for detail to uphold stringent quality standards.

Performs batch records review and cleaning records review to ensure product availability.

Support work orders review and confirm area cleanliness after maintenance interventions.

Performs area walkthroughs to ensure audit readiness at all times.

Contribute to continuous improvement initiatives by suggesting and piloting novel QA methodologies tailored to dynamic manufacturing environments.

Document and communicate quality findings through clear, concise reports that facilitate swift decision-making and process optimization.

Maintain accurate and timely quality records related to product inspections, nonconformance, and project outcomes.

Assist in documenting, monitoring, and following up on corrective and preventive action plans to ensure their effective implementation and closure.

Respond to routine inquiries regarding technology transfer and improvements in manufacturing processes.

Collect, organize, and analyze data to prepare detailed reports for assigned quality processes.

Document and implement improvements to quality systems and standard operating procedures, including maintaining SOPs for interactions with contract manufacturers.

Gather and maintain documentation required for audits and inspections to ensure inspection readiness.

Support special quality projects and contribute to continuous quality improvement initiatives.


Required Qualifications

Bachelor’s degree or equivalent qualification in Engineering, Quality Management, Science or a related field demonstrating foundational technical knowledge.

2 years of practical experience or internships in quality assurance, manufacturing, or related operational environments.

Strong attention to detail and ability to maintain accurate documentation.

Basic understanding of investigations and automation processes.

Ability to collect, organize, and analyze data effectively.

Good communication skills to respond to routine technical inquiries.

Ability to work independently.

Ability to work night shifts and weekends.


Desired Qualifications

Strong analytical mindset with the ability to interpret complex data and translate it into actionable quality improvements.

Excellent communication skills to effectively collaborate with diverse teams and articulate quality concerns innovatively.

Familiarity with quality systems, audits, and inspection readiness.

Proactive learner with a passion for adopting emerging QA technologies and methodologies to drive shop floor excellence.

Proactive approach to supporting special quality projects and continuous improvement.

Not Specified
Materials Manager
Salary not disclosed
Horsham, PA 2 days ago

Avo Photonics ( ) is a dynamic contract engineering services company that designs, develops, and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to design, prototype and produce next generation products for a diverse range of markets including environmental, medical, military, industrial, aerospace, and communications.


We seek a diligent, dedicated, and meticulous person who will help to further our success and reputation in the industry. The successful candidate must plan his/her own work schedule to meet project deadlines, keep multiple records, be self-motivated and detail oriented, maintain a professional presence, and have the desire to take ownership of projects.


Specifically:

  • Manage Teams responsible for all materials including incoming inspection, inventory (stock room and manufacturing floor), reject control
  • Lead and manage the incoming inspection process for all materials and components, ensuring timeliness and compliance with quality standards and specifications
  • Communicate issues to Procurement
  • Oversee inventory organization and ensure timely distribution of materials on a 24/7 basis
  • Manage materials reconciliation processes to ensure accuracy and consistency
  • Conduct root cause analysis for inventory discrepancies and implement corrective actions
  • Understand and control rejected material returned to the inventory room and ensure proper and timely disposition
  • Partner with Procurement Manager to return rejected material discovered on production floor
  • Support accounting of recovered materials
  • Be highly organized and efficient at prioritizing workload


Requirements:

  • BS in business, accounting, operations, or related discipline
  • 10 years experience with management of Materials in a manufacturing environment
  • Expertise with an ERP system (SAP preferred)
  • 7 years management experience of small teams
  • Experience operating within an ISO9001-certified company
  • Outstanding verbal and written English communication skills
  • Attributes: High attention to detail, organized, able to multitask, personable, motivated, willing to take initiative


Apply: Avo Photonics offers competitive salaries and a comprehensive benefits package. Qualified candidates are encouraged to apply!


Equal Opportunity Employer: Avo Photonics is not accepting unsolicited assistance from search firms for this employment opportunity. All resumes submitted by search firms to any employee of Avo Photonics by any method without a valid written contract in place with Avo Photonics will be deemed the sole property of Avo Photonics. No fee will be paid in the event the candidate is hired by Avo Photonics because of the referral or through any other means.

Not Specified
Deviation Management Specialist - I (Assistant)
Salary not disclosed
West Point, PA 3 days ago
Deviation Management Specialist - I (Assistant)

12 months


West Point, PA, USA, 19486

Description:

Qualifications:

*B.S./M.S. degree in appropriate engineering/scientific field

*Minimum of 0-3 years post-Bachelors degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry

*Previous experience in writing investigations for atypical events in a manufacturing environment

*Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities

*Demonstrated ability to work both independently and as a part of a cross-functional team

*Excellent written and verbal communication skills

Responsibilities:

*Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations

*This individual will be responsible for providing scientific support for manufacturing areas within Manufacturing Division

*This Individual will also develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and is required to utilize sound scientific and engineering principles to investigate process deviations

*Troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, development of corrective/preventative actions is required

*Analysis of complex problems through critical analytical thinking and the design/execution of laboratory/pilot scale experiments is required

*Off-shift work may be required
Not Specified
Radiology Technician
Salary not disclosed
Warwick, PA 5 days ago
Job Details
Join the mission of Improving Lives as a Staff Nurse at Jefferson Health. With more than 42,000 employees, we're the second largest employer in Philadelphia and the largest health system in the Philadelphia region. And our work to improve lives is never done.

Job Description

Staff Nurses are responsible for the following:


  • Performs patient procedures within the nursing scope of practice.


  • Practices safe medication administration and assesses patient responses to medication.


  • Participates in reviewing and/or implementing clinical pathways and care coordination.


The Staff Nurse will provide professional nursing care to a group of patients within a specified time period and complete all required documentation.

Qualifications for this position include:


  • BSN Degree p referred


  • State Issued RN license


  • Basic Life Support (BLS) certification from the American Heart Association

  • ICU experience strongly preferred


Work Shift
Workday Night (United States of America)

Worker Sub Type
Regular

Employee Entity
Albert Einstein Medical Center
Primary Location Address
559 W. Germantown Pike, East Norriton, Pennsylvania, United States of America

Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University , home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health , nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.

Jefferson is committed to providing equal educa-tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status.

Benefits

Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps ), have access to medical (including prescription) insurance.

For more benefits information, please click here

By applying, you consent to your information being transmitted to the Employer by SonicJobs.
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permanent
Radiologist Jefferson Einstein Montgomery Hospital
🏢 Jefferson Health
Salary not disclosed
East Norriton, PA 6 days ago

Jefferson Einstein Montgomery Hospital | East Norriton, PA

Sign-On Bonus


Job Description Summary


Jefferson Einstein Montgomery Hospital (JEMH) is seeking a fellowship-trained Radiologist to join our Radiology Department and further enhance the comprehensive imaging services provided to our patients. This role offers the opportunity to practice in a modern, technologically advanced environment within a collegial and high-performing health system.


Jefferson Einstein Hospital proudly carries forward a legacy of excellence established in 1866. Today, we remain deeply committed to delivering compassionate, high-quality care while continuing to lead through innovation across the Greater Philadelphia region.


Jefferson Einstein Hospital continues to invest in its physicians through a newly revised compensation plan and a system-wide implementation of Sectra PACS in 2026, reinforcing our commitment to innovation, efficiency, and radiologist satisfaction.


Summary of Responsibilities

  • Interpret a broad range of diagnostic imaging studies, including MRI, CT, ultrasound, and X-ray, with a focus on body imaging
  • Provide accurate, timely, and high-quality radiologic interpretations to support patient diagnosis and treatment planning
  • Collaborate closely with referring physicians and multidisciplinary healthcare teams
  • Maintain proficiency in evolving imaging technologies, protocols, and best practices


Compensation & Benefits

  • Newly revised compensation plan offering competitive base salary with performance-based incentives
  • Sign-on bonus, paid within the first month
  • Full comprehensive benefits package
  • Medical, dental, and vision insurance
  • Retirement plans: Pension, 403(b), 457, and structured portfolio investment options
  • PTO
  • CME
  • Short and Long-term disability coverage
  • Malpractice insurance with tail
  • Life insurance


About Jefferson

Nationally ranked Jefferson Health is a leading not-for-profit academic health system headquartered in the Greater Philadelphia region, with a broad presence across Pennsylvania, New Jersey, and the Lehigh Valley. With a workforce of more than 65,000 team members, Jefferson is dedicated to delivering high-quality, compassionate patient care; strengthening the communities it serves; educating the next generation of healthcare leaders; and advancing innovation through clinical and applied research.


Thomas Jefferson University, founded in 1824, is home to Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce. Today, the University encompasses 10 colleges and three schools, offering more than 200 undergraduate and graduate programs to over 8,300 students.


Jefferson Health is consistently recognized as one of the top 15 not-for-profit healthcare systems in the United States, serving millions of patient encounters annually across 32 hospital campuses and more than 700 outpatient and urgent care locations. Jefferson Health Plans further extends Jefferson’s mission as a not-for-profit managed care organization serving Pennsylvania and New Jersey for more than 35 years.


Equal Opportunity Statement

Jefferson is committed to providing equal educational and employment opportunities for all individuals and does not discriminate based on age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military or veteran status, disability, or any other legally protected status.


Join Jefferson Health — where your career, your voice, and your impact truly matter.

Learn more, apply today!


Jason Kendall


Talent Acquisition Partner, Physician Recruitment

Thomas Jefferson University and Jefferson Health

T (314) 327-4574 cell/text |

| |

Not Specified
Application Scientist
Salary not disclosed
Collegeville, PA 6 days ago

Immediate need for a talented Application Scientist. This is a 12+ Months Contract opportunity with long-term potential and is located in Collegeville, PA (Onsite). Please review the job description below and contact me ASAP if you are interested.


Job Diva ID: 26-06212


Salary Range: $40-$46/hr . Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).


Key Responsibilities:


  • Leverage integrated assay automation platform to execute medium-high-throughput cell-based screens and assays in collaboration with therapeutic area and functional area scientists.
  • Train equipment users on key concepts associated with the platforms to support best practices and mitigate avoidable run failures, ensuring optimal routine operation.
  • Assist with programming the automated platform for assay protocol development.
  • Act as the 'first-responder' for troubleshooting and error recovery.
  • Maintain cell lines and primary cell cultures.
  • Demonstrate flexibility in accommodating rapidly changing priorities and deadlines.
  • Manage laboratory inventories.
  • Ensure compliance with laboratory safety procedures and guidelines.
  • Support equipment maintenance and establish strong relationships with OEM Service Organizations.
  • Interact with other engineers to leverage platform/systems knowledge to minimize instrument downtime.
  • Maintain training and compliance in areas of health and safety, security, environmental, and operational aspects of daily activities in the working environment.
  • Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.


Key Requirements and Technology Experience:


  • Key skills: - [“TECAN”, “PROGRAMMING”, “AUTOMATION”]
  • Bachelor’s degree in Engineering, Life Sciences, or related discipline with 2 years of experience in laboratory automation and/or lab instrumentation support OR Associate degree with 5+ years of experience in laboratory automation and/or lab instrumentation support.
  • Experience with equipment such as Tecan Fluent, Combi, BlueWasher, Cytomat, Liconic, WDII, PlateLoc, Xpeel, Cytation, Pherastar, Vspin, Echo.
  • Ability to work in a multidisciplinary team-based environment.
  • Proficient in cellular and biochemical assay techniques.
  • Experience with immortalized and/or primary cell culture.
  • Knowledge of device networking and communications protocols.
  • Experience of scripting and other advanced programming language
  • Tecan Fluent Programming is a must have skill.
  • At least 2 years of relevant experience.


Our client is a leading Pharmaceutical industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration


Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.


By applying to our jobs, you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

Not Specified
Senior Commissioning Engineer
Salary not disclosed
Spring House, PA 6 days ago

Senior Commissioning & Qualification Engineer – Automation (Biopharma Build)

Owner’s Representative | Onsite – Spring House, PA

Contract through end of year, potential for ongoing extensions


We are seeking a senior Commissioning & Qualification (C&Q) Automation SME to support the delivery of a state-of-the-art Cell & Gene Therapy manufacturing facility.

This is a high-visibility, onsite role where you will serve as the Owner’s Representative, ensuring highly automated GMP process systems are properly commissioned, integrated, and inspection-ready. If you thrive in complex, automation-heavy capital projects, this is the type of build that defines careers.


What You’ll Be Doing

  • Act as the technical SME for commissioning automated process equipment
  • Represent the owner’s interests across all project phases
  • Lead execution of Commissioning Plans with emphasis on automation, integration, and data integrity
  • Author and review IQ/OQ/PQ protocols, URS, and validation documentation
  • Oversee startup and field execution for complex equipment platforms
  • Drive resolution of automation-related deviations and integration issues
  • Coordinate across automation, construction, validation, quality, and vendor teams
  • Apply risk-based qualification principles (ASTM E2500, FMEA)
  • Ensure compliance with GMP, FDA, and 21 CFR Part 11
  • Support digital validation platforms (e.g., Kneat)


Equipment & Systems Scope

  • Cell & gene therapy manufacturing systems
  • Fill/Finish lines
  • Isolators
  • Integrated process equipment platforms
  • PLC / SCADA / DCS automation layers


What We’re Looking For

Required:

  • Bachelor’s degree in Engineering or Life Sciences
  • 5–10 years of CQV experience in automated biopharma manufacturing
  • Hands-on experience with process equipment and control systems
  • Strong understanding of GMP validation lifecycle

Strongly Preferred:

  • DeltaV, Rockwell, Siemens, or similar DCS/PLC platforms
  • Experience in greenfield or large capital projects
  • ASTM E2500 / GAMP 5 knowledge
  • Experience with digital validation tools (Kneat, Veeva)
  • Background in cell & gene therapy, fill/finish, or cleanroom environments

Why This Role?

  • High-impact, automation-heavy greenfield project
  • Owner-side authority and visibility
  • Complex, integrated GMP systems
  • Opportunity to shape commissioning strategy at a flagship facility


EEO Statement:

  • Eight Eleven Group provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.
Not Specified
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