Senior Validation Engineer

ZipRecruiter; Worcester; On-site; GBP 50,000 - 70,000; Full time

Job summary

A global biopharmaceutical company is seeking an experienced Engineer to join their Validation Engineering Group. This role involves commissioning and qualification activities for biopharmaceutical process equipment in an FDA-regulated environment. Candidates should have at least 5 years of experience in validation and a BS in engineering. Strong technical writing, organizational skills, and the ability to work in a fast-paced team are essential.

Qualifications

• 5+ years of experience supporting biologics manufacturing.
• Familiarity with Clean-In-Place and Steam-In-Place theory.
• Experience with risk-based approach to commissioning.

Responsibilities

• Prepare validation test protocols and analyze test results.
• Execute projects according to Engineering Project Management schedules.
• Mentor junior engineers in development and execution of plans.

Skills

Validation of biologics equipment

Technical writing skills

Process instrumentation knowledge

Interpersonal skills

Project management

Education

BS Degree in engineering or technical discipline

Tools

Kaye Validator

Distributed control systems

Job description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

Job Description

Purpose

AbbVie Bioresearch Center in Worcester, MA is seeking an Engineer with significant experience in the validation of biologics equipment to join the Validation Engineering Group.

The selected candidate will be responsible for commissioning and qualification activities associated with capital projects involving the installation and/or renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA/GMP regulated environment. The engineer will work in a multi-disciplinary team environment.

Responsibilities:

1. Prepare validation test protocols, set validation strategy, perform/coordinate validation testing for capital projects of different complexity in concert with all stakeholders, and analyze/assemble test results to create summary reports as required
2. Execute assigned projects, jobs, and tasks according to schedule prepared by Engineering Project Management
3. Provide input on risk assessments and system classifications
4. Review new equipment specifications
5. Manage continuous improvement projects and drive to completion
6. Mentor and guide junior engineers and validation associates in the development and execution of equipment change control plans and qualification/validation test protocols
7. Work with appropriate departments and personnel to resolve validation testing issues
8. Advise other departments on SOPs related to validation projects
9. Maintain 100% on-time training
10. Achieve Site, Department, and Group performance metrics
11. Complete other special projects and assignments as required
12. Comply with all regulatory, corporate, and site quality system procedures, especially safety and cGMPs

Qualifications

Key Stakeholders

Engineering Management, Operations Management, EH&S Management, R&D Management

Additional Information

• BS Degree in engineering or technical discipline with a minimum of 5+ years of experience supporting biologics manufacturing through validation of biologics equipment or processes.
• An understanding of basic unit operations involving cell culture and protein purification is required
• Working knowledge of bioreactors, sanitary equipment, hygienic piping, process instrumentation, and controls is required
• Familiarity with Clean-In-Place and Steam-In-Place theory and techniques is required
• Experience with risk-based approach to commissioning and qualification
• Experience with temperature mapping of environmental chambers, autoclave validation is desired
• Familiarity with distributed control systems and process logic controllers is required
• Must have familiarity with P&IDs, loop diagrams, etc.
• Must have hands-on experience on the Kaye Validator
• Familiarity with project management is desirable
• Experience with continuous improvement to streamline practices & procedures is desirable
• Adherence to cGMP and GDP is required
• Strong technical writing skills are required
• Strong organizational, prioritization, technical, mechanical, and communication skills as well as experience in a GMP environment are required
• Ability to work independently with adequate supervision, multi-task, and support several projects simultaneously
• Strong interpersonal and teamwork skills

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

Applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html