CQV Engineer Automation Digital 3602SS

Who are we:

Verista's 700 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. Whether it's compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

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

Typical Responsibilities Include:

CQV Engineer Automation Digital

Reporting to the MAP CQV Lead and MAP CQV Automation Work Stream Lead, the role of the CQV Engineer is to prepare and execute all CQV documentation applicable to the automation/digital workstream.

• Provide management and strategy for entire manufacturing, packaging lines or facility validation efforts.

• Operate according to SOPs developed for MAP Project Qualification strategy and general GEP / cGMP compliance.
• Provide or arrange for development of complete verification documentation in accordance with Quality Standards and cGMP requirements for assigned projects.
• Raise and Implement system change controls as required.
• Develop and implement changes required to resolve deviations/ non conformances effectively.
• Participate in design review for new/ modified automation systems such as ECS, CCMS, EMS
• Participate in ERES - Data integrity assessments
• Author and perform System Risk Assessment (SRA)
• Author and perform execution of Verification esting (Qualification) Protocols (VTPs) in field.
• Effectively interact with leadership and partner with Engineering Verification, Engineering Project Management, Automation, Maintenance, Operations, and Quality stakeholders to establish priorities and define verification documentation and testing requirements for the portfolio of systems within the assigned area.
• Collaborate with matrix organization to optimize Equipment Verification/Validation/Change Control implementation.
• Attend weekly meetings to report on progress and set up meetings as required.
• Adjust day-to-day role requirements depending on the immediate demands and requirements set down by the project as a whole.
• Work with all other project personnel to ensure successful project delivery
• Assist with pre and post study calibration verifications.
• Participate in construction system mechanical completion walkdowns.

Requirements

• Minimum of a Bachelor of Science (BS) Degree in Engineering or Related Discipline from a fully accredited institution.
• Minimum of 4 years of engineering and/or project management experience in systems Qualifications.
• Experienced in a pharmaceutical / FDA-regulated manufacturing environment is a must. A solid working knowledge of cGMP and automation validation requirements, automation systems such as ECS, CCMS, EMS.
• EDES (Kneat), or PDOCS or Trackwise (QTS)
• Excellent oral and written communication skills, including presentations.
• Demonstrated commitment to values-based leadership and achieving objectives in a manner that is supportive of the Pfizer Values and Leader Behaviors.
• Ability to write clearly, concisely, and persuasively in a professional environment.
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Benefits

Because employees are the key to our success, Verista offers strong benefits and incentives including:

• Health, Dental, and Vision Insurance
• 401(k) Retirement Plan with a company match
• Paid Time Off Pay
• Tuition Reimbursement
• 9 Company Paid Holidays
• Paid Long Term & Short Term Disability Insurance
• Training and Development
• Paid Maternity Leave and Parental Leave
• Travel Bonus
• Employee Referral Program
• Tuition Reimbursement
• Marriage Leave
• Bereavement

*Verista is an Equal Opportunity Employer

For more information about our company, please visit us at Verista.com or follow us on LinkedIn.

*Verista is an equal-opportunity employer.

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.

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