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Senior Validation Engineer

Company: Verista
Location: Berkeley
Posted on: January 16, 2023

Job Description:

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

Validation Engineer Responsibilities:

Authoring and executing technical commissioning and qualification documentation for complex, automated equipment, and processes, which includes compliance with client's quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 2XX and 8XX level standards which apply to the equipment and product being validated) and national/international standards. Completing commissioning and validation activities taking an engineering approach including identifying performance issues and solutions, recommending design or process modification, and verifying that our clients' equipment maintains SISPQ.

Authoring, editing, and executing validation documents for equipment, facilities and/or utilities including but not limited to: Life cycle document management

System requirements and description (URS)

System boundary definition

Traceability matrices

Design Qualification (DQ) including Functional Design and Software Design Specification Development

Start Up and Debug documentation

Commissioning document development and execution, including FAT and SAT

IQ/OQ/PQ

Turnover documentation

Designing and executing engineering studies for critical process parameter definition and verification prior to validation.

Conducting and documenting impact and risk assessments with a full understanding of equipment operation and ability to assess direct, indirect, and no impact systems and functions within complex, high speed automated process and packaging equipment

Verifying system drawings including ability to review and as-built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer. --- Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment.

Completing user interface testing, software verification, and complete alarm testing on automated manufacturing equipment (e.g., Rockwell RSView ME user interface and AB ControlLogix PLC).

Performing onsite validation Verista's clients.

Developing, reviewing, and completing Installation Check (IC) documentation; including verification of engineering components, drawings and specifications utilizing technical engineering background and expertise.

Developing and conducting computer system validation.

Owning entire CQV process for and adherence with project schedule for all assigned equipment and components.

Maintaining clear, detailed records of qualification, and change control activities for future compliance audits.

Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis and address complex automated equipment issues to ensure successful validation and compliance.

Working with vendors to ensure equipment meets design intent/specifications (IQ/CQ).

You will have:

This position requires a minimum of a Bachelor's degree in an Engineering or Scientific degree.

Experience in GMP regulated environment.

Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls).

Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls

Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including: Good Documentation Practice (GDP) in pharmaceutical environment

ASTM-E2500

ISO 14971 - risk management for medical devices

ISPE Applied Risk Management for C&Q

ISPE Science and Risk Based Approach for the delivery of facilities, systems, and equipment

ICH 8, 9, 10 - Knowledge of Risk management and Risk Analysis Tools

21 CFR Part 2XX and 8XX level regulations and interpretation as applied in the above standards.

Experience and knowledge of mechanical systems and clean utilities including ability to read electrical, mechanical, P&ID (piping and instrument) and facility drawings

Desired Skills:

Temperature Mapping

Perform variety of CQV projects/studies in areas including Equipment commissioning and qualification, as well as utilities, facilities, and support systems projects/studies to support manufacturing. Perform IQ, OQ, PQ of Bioreactors, Refrigerators, coolers, freezers, flow hoods, BSC, incubators, stability chambers, cold rooms, water systems, mixers.

Lead/Train others

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 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 or follow us on .

*Verista is an equal-opportunity employer.

#LI-AE1

Keywords: Verista, Berkeley , Senior Validation Engineer, Other , Berkeley, California

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