- Provide technical support for ensuring that current versions of the Computer System are qualified through verification and maintained in a qualified state
- Accurately record data and performing statistical analysis where applicable during execution
- Adhere to company procedures and government regulations such as Good Documentation Practices (GDP), GAMP and 21 CFR part 11 when executing protocols
- Document deviations and non-conformances that occur as a result of the qualification
- Collaborate with Management, Developers, Implementation, business development and client representatives to meet deliverable(s)
- Route, Approve, Develop and Revise Requirement Specifications, Test Scripts, Validation Master Plans, supporting documentation for validation, admin manuals and software documentation where applicable
- Coordinate with reviewers and approve to finalize documentation
- Perform a review of quality systems and manufacturing data, summarize and draw conclusions to be included in individual product assessments
- Execute Qualification Protocols
- Track and communicate progress of deliverable(s)
- Communicate complications or issues in the validation process
- Other duties as assigned
- Bachelor's Degree in engineering or related field
- Minimum 5 year of validation related experience
- Knowledge of writing and reviewing validation documentation
- Good understanding of IQ, OQ, PQ, RTM, Test Scripts, Summary Reports, etc
- Strong Attention to Detail
- Self-motivated and reliable
- Knowledge of PC computer operating systems and the Microsoft Office suite
- Strong written and oral communication skills
- 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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CSV Engineer - Devens, United States - DPS Group LLC
Description
SummaryDPS Group is seeking a CSV (MES) Engineer to support a client in Devens, MA. The candidate must have MES 3.0 and experience in a pharma/biotech GMP Environment.
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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