Energy Jobline ZR
6011 - Senior Lab CSV Engineer / Senior Validation Engineer in Muskegon
Energy Jobline ZR, Muskegon, Michigan, United States, 49444
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
Senior Lab CSV Engineer / Senior Validation Engineer Responsibilities: We are looking for a skilled lab equipment validation/CSV resource. The qualified candidate must have worked with and validated simple and complex lab instruments, performed execution of instruments with no guidance and interfaced with instrument vendors to determine scope of testing.
Knowledge and demonstrated experience of Computerized System and Lab Equipment Validation
Understanding with demonstrated experience drafting and executing validation documents, such as Val Plans, URS, IQ/OQ/PQ protocols, RTM, VSR, Deviation Management, Change Management and Project Management
Conducting and documenting impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes
Experience with requirements gathering and root cause analysis activities
Adherence with project schedule for all assigned activities
Maintaining clear, detailed and compliant qualification and validation records
Understanding of system design and/or configuration activities
Understanding of system integrations, including but not limited to understanding of how integrations are designed/constructed, data flow from source systems to target systems, typical testing approach for system integrations
Requirements
Bachelor's Degree or equivalent required
4 to 6 year of relevant role specific experience
Proficiency using PC and Microsoft Office tools
Ability to work as part of a team and independently
Strong problem-solving and critical thinking skills
Excellent organizational and time management skills
Strong attention to detail
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization
Experience in pharmaceutical cGxP setting with the ability to generate CSV deliverables
Knowledge of 21 CFR Part 11 regulation
Direct experience and understanding of complex lab equipment/systems
This is an on-site role in Muskegon, MI.
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.
*Verista is an equal opportunity employer.
(US) Range$70,491—$122,603 USD
Benefits Why Choose Verista?
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 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
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
Senior Lab CSV Engineer / Senior Validation Engineer Responsibilities: We are looking for a skilled lab equipment validation/CSV resource. The qualified candidate must have worked with and validated simple and complex lab instruments, performed execution of instruments with no guidance and interfaced with instrument vendors to determine scope of testing.
Knowledge and demonstrated experience of Computerized System and Lab Equipment Validation
Understanding with demonstrated experience drafting and executing validation documents, such as Val Plans, URS, IQ/OQ/PQ protocols, RTM, VSR, Deviation Management, Change Management and Project Management
Conducting and documenting impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes
Experience with requirements gathering and root cause analysis activities
Adherence with project schedule for all assigned activities
Maintaining clear, detailed and compliant qualification and validation records
Understanding of system design and/or configuration activities
Understanding of system integrations, including but not limited to understanding of how integrations are designed/constructed, data flow from source systems to target systems, typical testing approach for system integrations
Requirements
Bachelor's Degree or equivalent required
4 to 6 year of relevant role specific experience
Proficiency using PC and Microsoft Office tools
Ability to work as part of a team and independently
Strong problem-solving and critical thinking skills
Excellent organizational and time management skills
Strong attention to detail
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization
Experience in pharmaceutical cGxP setting with the ability to generate CSV deliverables
Knowledge of 21 CFR Part 11 regulation
Direct experience and understanding of complex lab equipment/systems
This is an on-site role in Muskegon, MI.
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.
*Verista is an equal opportunity employer.
(US) Range$70,491—$122,603 USD
Benefits Why Choose Verista?
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 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