Engineering Jobs in Skippack, PA
39 positions found — Page 2
The Business Data Analyst will play a critical role in supporting data-driven decision-making for core PMA business functions. This position is focused on extracting valuable insights from complex datasets, creating operational reports, and developing intuitive BI dashboards tailored to business needs. Working within an enterprise reporting structure, the analyst will perform on-demand data discovery, conduct trend analysis, and develop analytics tools that empower stakeholders with meaningful insights. By ensuring data accuracy, quality and relevance, this role will support data governance activities and continuous process improvements that align with strategic objectives.
Responsibilities:
Data Analysis & Business Insights
* Conduct in-depth data analysis to support strategic business initiatives.
* Perform trend analysis and develop predictive insights to help business teams identify patterns, risks, and opportunities.
* Respond to data discovery requests and operational reports development to support key business metrics and decision-making.
* Deploy best practices and make recommendations for improved understanding.
* Translate complex data findings into actionable recommendations, presenting insights in a clear and meaningful way for non-technical stakeholders.
Enterprise Reporting & BI Dashboard Development
* Work closely with business stakeholders to understand their reporting needs, providing insights that drive data-informed decisions.
* Design, develop, and maintain interactive BI dashboards tailored to answering critical business questions, providing real-time access to critical metrics and performance insights.
* Utilize enterprise BI tools to create data visualizations that enable easy exploration of data and insights.
* Partner with stakeholders to test and refine dashboards, ensuring they align with business requirements and enhance decision-making capabilities.
* Facilitate training and support for business users on BI dashboards and reporting tools, enabling self-service access to data insights.
Data Quality Support & Validation
* Collaborate with data governance and data engineering teams to ensure high data quality and integrity in enterprise reports and dashboards.
* Perform data validation and verification as part of report development to ensure data accuracy, consistency, and relevance for business users.
* Monitor data accuracy metrics and support data issue resolution, maintaining a high standard of data quality across reporting tools.
* Demonstrate commitment to Company's Code of Business Conduct and Ethics, and apply knowledge of compliance policies and procedures, standards and laws applicable to job responsibilities in the performance of work.
Requirements:
* 3+ years of experience in data, analytics, or business intelligence.
* Bachelor's degree in Information Management, Data Science, Computer Science, Mathematics, Statistics, Economics, Psychology or a related field.
* Proficient in SQL for data extraction and manipulation across various data sources.
* Strong analytical skills to interpret complex datasets and draw actionable insights.
* Experience with BI platforms like QlikSense or Power BI for data visualization and dashboard development.
* Familiar with advanced Excel functions for data manipulation and reporting.
* Understanding of statistical methods and trend analysis for identifying patterns and creating projections.
* Familiar with predictive modeling or basic machine learning concepts is a plus.
* Proficiency with scripting languages or tools (such as Python, R, or VBA) for process automation is a plus.
* Basic understanding of data integration, ETL processes, and data warehousing concepts.
* Skilled in presenting data in a way that tells a compelling story and drives informed decision-making.
* Strong interpersonal skills to work effectively with cross-functional teams in underwriting, finance, and IT.
* High level of precision in data analysis, ensuring reports and insights are accurate and free of errors.
* Analytical mindset to investigate data challenges, identify root causes, and develop efficient solutions.
* Ability to adapt to evolving data requirements and troubleshoot issues with minimal supervision.
* Strong organizational skills to balance multiple projects and meet reporting deadlines.
* Effective time management to handle ad hoc requests and prioritize tasks in a fast-paced environment.
* Open and motivated to learn new tools, methods, and data practices.
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.
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.
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
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.
See Jefferson Health Privacy Policy at and SonicJobs Privacy Policy at and Terms of Use at
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.
See Jefferson Health Privacy Policy at and SonicJobs Privacy Policy at and Terms of Use at
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.
See Jefferson Health Privacy Policy at and SonicJobs Privacy Policy at and Terms of Use at
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 |
| |
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.
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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.
