5896 - Senior Process Engineer 2 / Senior CQV Engineer

Verista, Inc.Novato, CA, US

30+ days ago

Job type

Full-time

Job description

Job Description

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

Senior Process Engineer 2 Responsibilities :

Meet with client stakeholders and SMEs to develop Process Validation (PV) protocols in preparation for and throughout Process Performance Qualification (PPQ)

Coordinate execution of PV protocols, including sampling, testing, data tracking, and data collection with various internal functional groups and external contract labs

Summarize execution of PV protocols in final reports and prepare final packages for SME review and approval

Manage the responsibilities on multiple simultaneous projects and / or clients

Drive the activities as client facing leader and responsible party.

Act as the defined point of escalation and issue management on client projects

Requirements :

Ability to take independent leadership role on project(s)

Coordination and direction of process validation activities involving cross functional teams including Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others

Some trips to Novato, CA site 1 or 2 x a year may be necessary to oversee execution

Proven ability to identify areas of business expansion and initiate technical discussion on Verista solutions for business expansion

Demonstrated project leadership capabilities

Demonstrated experience with various stages of clinical and commercial manufacturing in a Quality and / or Process Sciences Role

Strong Understanding of process fundamentals and qualification / validation requirements for the following :

Small molecule chemical synthesis

Monoclonal antibody or protein biomanufacturing

Cell therapy and regenerative medicine

Sterile drug product fill / finish Analytical QC laboratories

Computer System

Packaging

Ability to architect Process implementations and execute against complex project tasks.

Advanced Microsoft Project capabilities.

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.

National (US) Range

$87,780—$131,685 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 Disability 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

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Senior Engineer • Novato, CA, US

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