Energy Jobline ZR
5950 - Senior CQV Engineer / Senior Validation Engineer 2 in Holly Springs
Energy Jobline ZR, Holly Springs, Georgia, us, 30142
Description
Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
We empower and support our colleagues
We commit to client success at every turn
We have the courage to do the right thing
We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
We constantly acquire new skills and learn from our experiences to enhance our collective expertise
CQV Engineer Responsibilities (Typical):
Downstream process and CQV support (ex. Chromatography, Centrifugation, Product Pooling, Filtration Systems)
Developing and reviewing, and SOP documentation
Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis
Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release
Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
Running test scripts and documenting results
Adherence with project schedule for all assigned activities
Maintaining clear, detailed records qualification and validation
Documenting impact and risk assessments as part of a team
Completing user interface testing, software verification, and complete alarm testing on automated systems
Developing, reviewing, and executing testing documentation
Making recommendations for design or process modification based on test results when executing test scripts
Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment
General understanding of capital equipment implementation and process knowledge
Understanding validation documents, URS, IQ, OQ, PQ
Verifying system drawings including ability to review and as-built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer
Requirements:
Must be able to meet onsite work requirements in Holly Springs, NC
Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution
Minimum 4 years technical experience
Demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment)
Demonstrated experience authoring and executing FAT, SAT, IOQ, CSV Protocols
Experience in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements
Communication Skills: Excellent oral and written communication skills, including presentations
Ability to write clearly, concisely, and persuasively in a professional environment
Demonstrated ability to interact effectively with all levels of the organization
Demonstrated understanding of risk-based approach to commissioning & qualification
Experience with testing of automated manufacturing equipment / systems (e.g., PLC-controlled)
Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
Ability to work as part of a team
Strong problem-solving and critical thinking skills
Excellent organizational and time management skills
Strong attention to detail
GMP and Good Documentation Practice
Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
Basic skills with EXCEL and PowerPoint
Strong interpersonal skills and clear communication capabilities
Experience with and tolerance for high levels of challenge and change
Experience in GMP regulated environment
Proven attention to detail and organization in project work
Capable of working on assigned tasks without mentorship
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
(US) Range$80,465—$136,225 USD
Benefits
High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
*Verista is an equal opportunity employer.
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
We empower and support our colleagues
We commit to client success at every turn
We have the courage to do the right thing
We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
We constantly acquire new skills and learn from our experiences to enhance our collective expertise
CQV Engineer Responsibilities (Typical):
Downstream process and CQV support (ex. Chromatography, Centrifugation, Product Pooling, Filtration Systems)
Developing and reviewing, and SOP documentation
Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis
Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release
Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
Running test scripts and documenting results
Adherence with project schedule for all assigned activities
Maintaining clear, detailed records qualification and validation
Documenting impact and risk assessments as part of a team
Completing user interface testing, software verification, and complete alarm testing on automated systems
Developing, reviewing, and executing testing documentation
Making recommendations for design or process modification based on test results when executing test scripts
Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment
General understanding of capital equipment implementation and process knowledge
Understanding validation documents, URS, IQ, OQ, PQ
Verifying system drawings including ability to review and as-built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer
Requirements:
Must be able to meet onsite work requirements in Holly Springs, NC
Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution
Minimum 4 years technical experience
Demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment)
Demonstrated experience authoring and executing FAT, SAT, IOQ, CSV Protocols
Experience in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements
Communication Skills: Excellent oral and written communication skills, including presentations
Ability to write clearly, concisely, and persuasively in a professional environment
Demonstrated ability to interact effectively with all levels of the organization
Demonstrated understanding of risk-based approach to commissioning & qualification
Experience with testing of automated manufacturing equipment / systems (e.g., PLC-controlled)
Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
Ability to work as part of a team
Strong problem-solving and critical thinking skills
Excellent organizational and time management skills
Strong attention to detail
GMP and Good Documentation Practice
Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
Basic skills with EXCEL and PowerPoint
Strong interpersonal skills and clear communication capabilities
Experience with and tolerance for high levels of challenge and change
Experience in GMP regulated environment
Proven attention to detail and organization in project work
Capable of working on assigned tasks without mentorship
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
(US) Range$80,465—$136,225 USD
Benefits
High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
*Verista is an equal opportunity employer.
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr