Validation Engineer II
A career at Resilience is more than just a job – it’s an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
The Validation Engineer is a hands-on position which will be responsible for providing support for maintenance, validation, and commissioning activities while ensuring current Good Manufacturing Practices are followed. The individual will be responsible for qualifying new equipment, maintaining regulatory compliance, and managing continuous improvements. The Validation Engineer will report to the Validation Manager and work collaboratively with a cross-functional team.
- Support all aspects of the Validation Life Cycle in Manufacturing from design through operation and improvement.
- Responsible for validating and qualifying GMP analytical instruments, equipment, utilities, and facilities.
- Responsible for supporting the preparation of validation documentation such as but not limited to qualification protocols, risk assessments, periodic reviews.
- Author, review and approve technical documents needed for qualification of equipment and processes.
- Coordinates validation activities with other departments to ensure validation projects are carried out on time and produces minimal down time.
- Work collaboratively with internal stakeholders and as necessary external partners/vendors.
- Work closely with equipment vendors to ensure thorough and accurate documentation is gathered during qualification processes.
- Maintains engineering and validation records in both hard copy and electronic form.
- Manages the design, specification, and installation of new/renovated process equipment and facilities modifications.
- Identifies and mitigates risks to ensure business continuity and protect the company from loss.
- Ability to collaborate and manage conflict in a fast-paced environment, working across functions.
- Prepare documentation of activities, actions, and/or results.
- Monitor records to ensure compliance with regulatory requirements.
- Ensure proper documentation practices during job activities.
- The ability to answer compliance and process questions.
- Communicate policies and procedures to employees.
- Communicate priorities and progress to team on a continuing basis.
- Initiate appropriate action when process deviations occur.
- Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.
- Participate in cross-functional teams to meet strategic goals.
- Read and interpret diagrams, drawings, and other schematics.
- Comfortable in a fast-paced, collaborative company environment, working with minimal direction and able to adjust workload based upon changing priorities.
- Participate in troubleshooting activities.
- Interact with regulatory agency personnel during audits and inspections.
- Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.
- Recommend compliance resolutions to management.
- Experience working in a regulated or cGMP environment.
- Ability to identify and implement solutions.
- Excellent oral and written communication skills with the ability to present results clearly and logically, working collaboratively as part of a team as well as independently.
- Demonstrated ability to work in a dynamic, fast-paced team environment and to meet timelines.
- Capable of multi-tasking and good organizational skills.
- Strong knowledge of cGMP Quality Systems. Proficient in Microsoft (Excel, Word, Outlook).
- Thorough understanding of cGMPs
- Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE.)
- 3 years of experience supporting validation or quality in a Biopharma cGMP environment.
- 4 Year Degree in Engineering / Science or equivalent
- Background in Laboratory Equipment
- Experience with Kneat
- Use and knowledge of different data logging devices
- Experience with Computer System Validation/ 21 CFR Part 11
The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $75,000.00 - $101,250.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.