Manufacturing Technical Writer/Deviation Writers (Contract Only) 3171AE

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

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.

Requirements

Manufacturing Technical Writer Responsibilities:

• Reviewing all project and system deliverables including but not limited to: Master Batch Records, plans, requirements, specifications, test protocols, scripts and associated execution deliverables, summary reports, and change controls
• Reviewing system operational and administration procedures to ensure they are adequate.
• Documenting any findings of non-compliance.
• Assisting with strategy regarding remediation activities.
• Documenting remediation activities.
• Assisting with review of remediation activities.
• Performs other duties as assigned.

You will have:

• You’ve earned your BS in chemical, biomedical, or biochemical engineering, biological sciences, or related field/experience.
• You’ve gained 2-10 years relevant industry experience working in a cGMP environment.
• You’ve got working knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biotechnology, pharmaceuticals, and medical devices in your toolbox.
• Experience quality assurance tasks and remediation actives.
• Experience reviewing Master Batch Records and validation documents.
• Experience with documenting remediation activities.

Desired Skills:

• Strong biologics experience
• Strong understanding of unit operations – cell culture, bioreactor, TFF, Chromatography, filtrations, etc.
• Strong knowledge of single use disposable systems
• Preferred experience in manufacturing but quality and/or validation setting exp is acceptable as long as unit operations familiarity exists
• Proven experience with authoring, reviewing, approving deviations/non-conformances
• Trained with understanding of RCA techniques – 5Whys, 6Ms, fishbone, etc.
• Have worked with batch records and have familiarity with workings of cGMP manufacturing environment
• Life science or engineering degree with at least 5+ yrs of direct relevant experience.
• Use of TrackWise system or similar operating framework
• Strong writing skills

If you are qualified, have leadership potential and a willingness to learn, Verista could be the right career choice for you!

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 for Employee option.
• 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 t