Talent.com
Validation Specialist
Validation SpecialistGannett Fleming • Allentown, PA, US
serp_jobs.error_messages.no_longer_accepting
Validation Specialist

Validation Specialist

Gannett Fleming • Allentown, PA, US
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

GFT is seeking a Validation Specialis tto join our Building and Places Group! This position can be based in Eastern Pennsylvannia or Central New Jersey.

  • This position requires a minimum of 3 days per week in-office or on-location, except during protocol execution periods which require 100% on-location effort
  • GFT office assignment location is negotiable
  • Client and OEM vendor sites vary per project, and the majority of work is expected to take place in eastern Pennsylvania and central New Jersey
  • This position requires occasional travel outside of the primary region : domestically and internationally (~15%)

What you’ll be challenged to do :

This is an excellent career opportunity for an experienced, motivated Validation Specialist who thrives in a collaborative team environment. The role highlights a customer-focused mindset and a passion for delivering exceptional quality and results on every project.

In this capacity, the successful candidate will be responsible for the following :

  • Author and execute CQV (Commissioning, Qualification, Validation) test case scripts / protocols for mechanical equipment, automated equipment / systems facilities and utilities.
  • Author validation plans, risk assessments, requirement and specification documents, traceability matrices, summary reports, and other supporting documentation for new and existing manufacturing equipment, processes, and products
  • Develop Standard Operating Procedures (SOPs) for mechanical equipment, automated equipment / systems, manufacturing processes, and facilities and utilities.
  • Specialized and demonstrated knowledge in the area of one or more of the following pharmaceutical manufacturing processes is required - computer system validation, automated equipment / systems qualification and validation, facilities and utilities commissioning and qualification, or primary and secondary packaging systems (strongly preferred)
  • Develop, oversee, and / or execute Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and Installation / Operational Qualification (IOQ) protocols for automated manufacturing and packaging equipment / systems, building automation systems, or other suppliers / vendors at the customers' or vendors' sites
  • What you will bring to our firm :

  • A four-year degree in a technical, manufacturing, or quality related field preferred
  • 5+ years experience with the authoring and execution of CQV documentation including validation documentation, technical protocols and / or technical reports preferred
  • 5+ years experience working in an FDA-regulated environment and working knowledge of FDA (and of other regulatory bodies) Regulations / Guidance, and Good Manufacturing Practices
  • Knowledge of instrumentation and pharmaceutical processes and facilities equipment
  • Strong preference given to candidates with packaging validation experience
  • Ability to handle multiple tasks, projects, or assignments simultaneously
  • Demonstrated proficiency with Microsoft applications (Word, Excel, PowerPoint).
  • Excellent verbal and written communication skills, as well as attention to detail, required
  • Must be able towork independently and to coordinate with team members in other offices
  • You will have the ability to travel to client locations in Eastern PA and Central NJ as projects assignments require; approximately 50% of your time
  • Ability to travel domestically for one to two weeks per trip for equipment FAT; approximately 10% of your time
  • Ability to travel internationally for one to two weeks per trip for equipment FAT; approximately 5% of your time
  • Ability to work flexible and overtime hours including evenings and weekends to meet business needs (occasionally)
  • Ability to work with multiple teams and clients, at multiple locations, and occasionally from a home office
  • Compensation : The salary range for this role $95,000 -$130,000 . Salary is dependent upon experience and geographic location. Featured Benefits :

  • Hybrid (in-person and remote) work environment.
  • Comprehensive benefits package including wellness programs, parental leave, and pet insurance, in addition to medical, dental, vision, disability, and life insurance.
  • Tax-deferred 401(k) savings plan.
  • Competitive paid-time-off (PTO) accrual.
  • Tuition reimbursement for continued education.
  • Commitment to professional development, access to internal and external training programs, and support of active participation in professional organizations
  • Incentive compensation for eligible positions. Physical Capabilities Required to Perform Job : Light Lift / Carry – less than 40 pounds, Read PC screens, read fine / normal print size, employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, wear job-site required personal protective equipment (PPE) such as lab coats, coveralls, safety shoes, shoe covers, safety glasses, hard hats
  • Mental Capabilities Required to Perform Job : Communicate utilizing a telephone, Compute / analyze / interpret data, Conduct / maintain interpersonal communication, Establish and meet deadlines, Organize / prioritize work, Understand complex problems / explore alternatives, Ability to work in a fast-paced work environment, Ability to work independently and as a team member

    At GFT, a privately held AEC firm, we innovate where transportation, water, power, and buildings converge. We call this the Infrastructure of Life. We measure our success by the strength of our relationships – that’s why we’re the employer of choice for 5,000+ of the industry’s brightest engineers, planners, architects, inspectors, designers, and more.

    Our clients choose us for our expertise and prefer us for our nimble approach, creativity, and personal touch. Backed by over a century’s experience, together we’re building a lasting legacy for future generations : stronger communities, a healthier planet, and better lives.

    GFT : Ingenuity That Shapes Lives is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veterans’ status or other characteristics protected by law.

    Unsolicited resumes from third party agencies will be considered the property GFT.

    Location : Central NJ or Eastern PA

    Core Business Hours : 8 : 00 AM – 5 : 00 PM

    Employment Status : Full-Time

    Salary Range : $95,000 -$130,000

    Salary dependent upon experience and geographic location

    GFT does require the successful completion of a criminal background check for all advertised positions.

    #LI -gb1

    #li-hybrid

    serp_jobs.job_alerts.create_a_job

    Validation Specialist • Allentown, PA, US

    Job_description.internal_linking.related_jobs
    QA Quality Specialist II - Sys

    QA Quality Specialist II - Sys

    B Braun Medical • Allentown, PA, United States
    serp_jobs.job_card.full_time
    Braun US Device Manufacturing LLC.Allentown, Pennsylvania, United States.Wednesday, Tuesday, Thursday, Friday, Monday.Other key product areas include nutrition, pharmacy admixture and compounding, ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Cardiac Cath Lab Technologist - $3,120 per week

    Travel Cardiac Cath Lab Technologist - $3,120 per week

    Treva Workforce • Bethlehem, PA, United States
    serp_jobs.job_card.full_time
    Treva Workforce is seeking a travel Cath Lab Technologist for a travel job in Bethlehem, Pennsylvania.Job Description & Requirements. Treva Workforce Job ID #3100869.Pay package is based on 8 hour s...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    QA Quality Specialist II - Sys

    QA Quality Specialist II - Sys

    B. Braun US Device Manufacturing LLC • Allentown, Pennsylvania, United States, 18101
    serp_jobs.job_card.full_time
    Braun US Device Manufacturing LLC.Allentown, Pennsylvania, United States.Wednesday, Tuesday, Thursday, Friday, Monday.Other key product areas include nutrition, pharmacy admixture and compounding, ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Accounts Receivable Specialist

    Accounts Receivable Specialist

    Aston Carter • Allentown, PA, US
    serp_jobs.job_card.full_time
    Accounts Receivable Specialist.This Accounts Receivable Specialist will be responsible for pulling invoices from the quote system and uploading them into a separate system to be sent out.The role i...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel CT Technologist

    Travel CT Technologist

    Malone Healthcare - Nursing • Bartonsville, PA, US
    serp_jobs.job_card.full_time
    Malone Healthcare - Nursing is seeking a travel CT Technologist for a travel job in Bartonsville, Pennsylvania.Job Description & Requirements. Radiologic Technologist / CT Technologist (Dual.Nig...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Quality Manager III

    Quality Manager III

    Pyramid Consulting, Inc • Swiftwater, PA, US
    serp_jobs.job_card.temporary
    Please review the job description below and contact me ASAP if you are interested.Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and pai...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Immunology Sales Specialist

    Immunology Sales Specialist

    Syneos Health / inVentiv Health Commercial LLC • Allentown, PA, United States
    serp_jobs.job_card.full_time
    You have what it takes : a competitive drive coupled with exceptional sales ability.In this role, you will be responsible for implementing the sales plan by delivering proficient sales presentations...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Aggregate & Asphalt Quality Control Technician

    Aggregate & Asphalt Quality Control Technician

    The H&K Group Careers • Sellersville, Pennsylvania, US
    serp_jobs.job_card.full_time
    We are always looking for the best, most qualified people to join our team.Pre-employment drug testing (EOE).Aggregate & Asphalt Quality Control Technician. Aggregate and Asphalt Quality Control tec...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Quality Specialist / Technical Writer

    Quality Specialist / Technical Writer

    Masis Professional Group • Bethlehem, PA, US
    serp_jobs.job_card.permanent +1
    Quality Specialist / Technical Writer.Contract with potential direct hire!.In this position, you’ll play a vital role in. Strive to proactively drive the Quality culture at the site and promot...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Computer Serialization Validation Engineer (Allentown)

    Computer Serialization Validation Engineer (Allentown)

    Sharp Services • Allentown, PA, United States
    serp_jobs.job_card.full_time
    This role is responsible for the development and implementation of computer validation activities related to computerized GMP systems and technology within commercial and clinical Sharp locations.U...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Cath Lab Tech - $2,653 per week in Bethlehem, PA

    Travel Cath Lab Tech - $2,653 per week in Bethlehem, PA

    AlliedTravelCareers • Allentown, PA, United States
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with CrossMed Healthcare Staffing to find a qualified Cath Lab Tech in Bethlehem, Pennsylvania, 18017!. At CrossMed Healthcare Staffing, we aim to create lasting impre...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Endocrinology Specialist

    Endocrinology Specialist

    Lehigh Valley Hospital • Analomink, PA, United States
    serp_jobs.job_card.full_time
    Position Overview Join our team of experienced endocrinologists in a busy inpatient and outpatient practice with a wide variety of endocrine cases. You'll have exposure to leading-edge technology, i...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Finishing Specialist Level 1 - Temporary

    Finishing Specialist Level 1 - Temporary

    Prototek Digital Manufacturing • Allentown, PA, US
    serp_jobs.job_card.permanent
    serp_jobs.filters_job_card.quick_apply
    Finishing Specialist, Level 1 About Prototek Prototek is a leading national provider of digital based manufacturing services including CNC machining, precision sheet metal fabrication, EDM, and add...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days
    Downstream Scientist

    Downstream Scientist

    Net2Source (N2S) • Lansdale, PA, US
    serp_jobs.job_card.full_time
    Title : Bioprocess Engineer – Downstream.Pay Range- $35 - $43 per hour on W2.BS in Science, Engineering, or related field heavily preferred. Experience working with adjuvant and LNP processing ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Scientist

    Associate Scientist

    SPECTRAFORCE • Swiftwater, PA, US
    serp_jobs.job_card.full_time
    Hours for each position may vary.All positions require employees to stay until a job is completed.Every employee must be able to work weekends, holidays and overtime if necessary.Days off may not b...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Fitness Specialist - East Stroudsburg, PA

    Fitness Specialist - East Stroudsburg, PA

    FOX Rehabilitation • Analomink, PA, US
    serp_jobs.job_card.full_time
    FOX is seeking a top caliber Fitness Specialist to join our growing team in the East Stroudsburg , PA.Start your career today and join our fight to abolish ageism. This position is 2 hours per week....serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Inventory Specialist

    Inventory Specialist

    Pennsylvania Staffing • Lansdale, PA, US
    serp_jobs.job_card.full_time
    Responsible for executing, monitoring, and training inventory best practices and standard operating procedures for the entire store, including both front end and pharmacy.Supports pharmacy inventor...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Specialist, Operations

    Specialist, Operations

    Merck • West Point, PA, US
    serp_jobs.job_card.full_time
    Building 50 Live Virus Vaccine Filling Facility Project Specialist.The Building 50 Live Virus Vaccine Filling Facility Project team is seeking a highly motivated individual to fill an open position...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted