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Veristas 700 experts team up with the worlds most recognizable brands in the life science industry to solve their business needs. Whether its 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
Verista is currently seeking Validation Engineers with experience in facilities, equipment and process validation within a pharmaceutical or biotechnology manufacturing environment to support CQV (Commissioning, Qualification & Validation) activities.
Typical Responsibilities Include:
CSV QA support in Durham, NC (on site 3 days a week). BAS experience nice to have, but not a requirement. Automation experience required. Strong knowledge of Data Integrity/ALCOA, Automation systems experience
Responsibilities will include QA review and approval of SDLC documents - RS, trace matrices, protocols, change controls.
Required experience:
- Pharma Manufacturing systems validation
- Quality experience needed.
Nice to have:
- Delta V
- PLC Systems
Review all IT CSV project and system deliverables including but not limited to:
o Plans
o Requirements
o Specifications
o Test Protocols, Scripts and associated execution deliverables (such as test incident reports, etc.)
o Summary Reports
o Change Controls
Review system operational and administration procedures to ensure they are adequate
Document any findings of non-compliance
Assist with strategy regarding remediation activities
Assist with review of remediation activities
Designing and executing validation including support of computer system validation protocols to ensure consistency of data production and compliance with clients quality standards (including internal ISPE referenced guidelines, client procedures, and 21 Code of Federal Regulations Part 2XX and 8XX level standards which apply to the equipment and product being validated). Ensuring product and process development activities have all necessary validation and supporting justification.
Developing technical documents utilizing a simple non-technical general description. This requires understanding of highly technical automated equipment. Running test scripts and making recommendations for design or process modification based on test results.
Owning validation process (or portion thereof) not only from an engineering standpoint but also from a client and team relationship standpoint.
Developing and writing technical change controls from a general non-technical description of the change to a product, process, equipment, protocol, packaging, outcome, or location of equipment.
Documenting the planning and design required to support the changes, approvals, and testing.
Managing the overall documentation development and approval process including explanation and justification of document testing, content, and strategy from a quality and regulatory standpoint to facilitate acceptance and approval of the document by required signatories.QA
Requirements
- Life Sciences industry experience including prior experience implementing systems within a GxP environment.
- Strong experience working with SDLCs.
- Strong written and oral communication skills.
- Strong interpersonal skills.
- Experience at working both independently and in a team-oriented, collaborative environment is essential.
- Flexible during times of change.
- Can conform and swiftly adjusts to shifting priorities, demands and timelines through analytical and problem-solving capabilities.
- Manages complex issues and risks and troubleshoots them as they arise. This role will regularly interface with all levels of the organization and with external vendor
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Benefits
Why Verista?
- High growth potential and fast paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company paid medical premiums.
- Company paid Life, Short-Term, and Long-Term Disability insurances
- Dental & Vision insurances
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- Leadership development training, career planning, and tuition reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Maternity, Parental Leave and Bereavement
Verista is a leading business, technology and compliance company that enables clients to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing, and distribution. This experience brings together decades of knowledge, the most advanced engagement platforms, as well as transformative technologies. This allows clients to benefit from the ease, efficiency, and trust that results from working with one partner who excels across specialties.
For more information about our company, please visit us at (link removed) or follow us on LinkedIn(link removed)>
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.
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Verista
