- Become familiar with the user, functional, installation, operation and performance requirements for assigned projects and tasks.
- Review requirements and source documentation P&IDs, RDs, URSs, SOPs, Specifications), for use in development of equipment commissioning and validation documents.
- Equipment validation protocol development, including drafting documents, managing review cycles and protocol approval.
- Support Validation Master Plan development
- Execution of equipment validation protocols (including use of Kaye Validator/temperature monitoring for autoclaves, SIP Systems, washer COP, CIP, FITs, etc.)
- Support Equipment Validation Report development, including drafting documents, managing review cycles and protocol approval.
- Support Validation Summary Report development
- Preparation and processing of turnover packaging and validation documentation in EDMQ (electronic document management system).
- Provide support for generation, resolution and closure of Equipment Validation related deviations and required documentation.
- Assist with coordination of activities between Client teams (validation, engineering, manufacturing, QC, etc.).
- Support resolution of engineering/validation issues found during equipment validation.
- Attending meetings as required to support equipment installation and operation
- Providing quality oversight and approval for validation documents as needed. (Function test, IQs, OQs, etc...)
- Support developing SOP's.
- Other tasks as requested or required by Client to support Equipment Validation for each project.
- Preform CQV activities on process equipment including but not limited to....
- Other duties as assigned
- BS (MS preferred), in Industrial, Process or Chemical Engineering
- Experience working in a multi-disciplinary design office or equivalent client team
- Experience preforming and executing CQV activities for process equipment
- Demonstrated CQV experience in design consultancy and/or client-site environments
- Knowledge of typical biotech/pharmaceutical manufacturing systems and equipment
- Excellent communication skills, both written and verbal
- Excellent teamwork and interpersonal skills
- Excellent analytic, problem-solving and decision-making skills
- Advanced time management and organizational skills
- Leadership skills, with a view to managing people
- Results and customer-oriented, strong communication skills
- Demonstrated ability to learn and quickly apply new concepts and technical information
- Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.
- Continuous Learning -Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.
- Culture - Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best-in-practice development, and pride in workmanship.
- Customer Services - Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service.
- Planning and Organizing - Prioritizes and Plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, Sets goals and objectives. Works in an organized manner.
- Teamwork - Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others' views. Gives and welcomes feedback. Puts success of team above own interests.
- Use of Technology - Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.
- Language Ability - Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees.
- Mathematical Ability - Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations.
- Reasoning Ability - Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.
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Senior Validation Engineer - Bedford, United States - DPS Group LLC
Description
SummaryThe CQV Engineer is responsible for executing and managing equipment, facility, utility, process, primary packaging validation activities and change management activities to meet cGMP requirements. They will need experience with cleaning validation of syringe filling m/c and mixing tanks, Environmental monitoring systems, and packaging machines (printers, labelers, assemblers, and cartooning m/cs).
Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
DPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a 'client-first' mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.
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