Process Validation Engineer III
Company: Yoh, A Day & Zimmermann Company
Posted on: April 10, 2021
Position location: Bedford, NH
The Process Validation Engineer III performs an array of
well-defined validation/qualification activities in support of cGMP
pharmaceutical/medical device contract manufacturing across
multiple CLIENT --facilities. These PV activities include working
with clients to define process control parameters and design
protocols to test and verify process robustness. The role requires
audit and inspection management support. In collaboration with
validation management, assist internal project teams and external
validation firms on validation/qualification initiatives and to
ensure project schedules are met. Complies with the requirements of
the Safety Program, including CLIENT --Health and Safety mandates
and OSHA requirements. In carrying out duties, PV Engineer
contributes and promotes a positive and equitable working
environment emphasizing the CLIENT --Values: Customer Focus,
Innovation, Integrity, Collaboration, and Superior Performance.
- Author Process qualification/ verification validation plans;
this includes the development of client specific process
requirements and specifications drafts to execute process
performance qualifications, process simulation media fill
protocols. Also compile trace matrices, perform data analysis,
draft validation protocol discrepancy reports and draft process
validation summary reports
- Author and perform the technical review of deviations and
planned deviations, change controls, perform process monitoring
(manufacturing data summary and analysis, data presentation),
perform activities for lot release (assess deviations and process
- Participate in client and Regulatory Audits. Work on CAPA and
Deviations with minimal but some oversight to achieve quality,
- Assist with determining impact of change control on qualified
process and aseptic operations.
- Work closely with other validation department personnel and
cross-functionally with MTS, Manufacturing, Engineering, Critical
Utilities, Quality Assurance, and project management to achieve all
- Assist management with mentoring and training of colleagues on
policies and procedures including the requirements for validation.
--Perform all functions associated with process validation
- Develop and recommend science-based solutions with a focus on
continuous improvement and compliance.
- Perform risk assessment and mitigation steps to achieve
validation requirements and ensure each process remains in a
validated state of compliance by compiling and analyzing data for
continued process verification.
- Coordinate and execute validation protocol activities with
consistent and effective communication with affected departments;
working autonomously while keeping the manager updated
- Work in a highly independent fashion, with minimal to no
direction in the execution of duties, while keeping teammates and
manager informed and providing guidance to other engineers as
- Write process validation and process simulation media fill
protocols and technical study approaches.
- Experience in pharmaceutical or biopharmaceutical environment
- Skilled in the development and execution of PPQ's. Review
commissioning, qualification and validation related system
lifecycle documentation (user requirements, functional and design
specifications, commissioning and qualification
- Combination of equipment qualification, process validation, or
cleaning validation is acceptable; QA pharmaceutical experience
- Validation experience with the following is highly preferred:
Thermal characterization, Vacuum physics, Heat and mass transfer,
Formulation, Aseptic Filling and Lyophilization, Steam
Sterilization, data analysis and statistics.
- Engagement and knowhow with regulatory inspections and
knowledgeable in current industry standards and regulatory trends
as they pertain to Validation of pharmaceutical or
- Knowledge of Industry guidelines (ISPE, PDA), US and
international regulations (FDA, ICH, ISO, EMA) for validation of
- Possess strong knowledge of Process Performance Qualification
/Validation practices, including applicable regulations.
- Excellent technical writing, verbal communication and
- Proficiency in Microsoft Office including Word, Excel, Power
- Bachelor of Science degree in Chemical Engineering,
Biochemistry, Biology or related scientific discipline required
with a minimum of 6 years of Pharmaceutical industry experience or
combination of work experience in Validation, QA, MFG, MTS, Process
Development or Engineering.
- Organized individual who is accustomed to working in a result
oriented-focused, dynamic CMO environment.
- Professional and collaborative team player must have strong
- Honesty, integrity, respect and courtesy with all
- Ability to inspire others to strive for excellence.
- Self-motivated and able to meet goals with minimal
PHYSICAL REQUIREMENTS & MENTAL DEMANDS
- Ability to lift 50 pounds
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, disability, or status as a
protected veteran. Visit
https://www.yoh.com/applicants-with-disabilities to contact us if
you are an individual with a disability and require accommodation
in the application process.PandoLogic. Keywords: Quality Control /
Quality Assurance Engineer, Location: Bedford, TX - 76095
Keywords: Yoh, A Day & Zimmermann Company, Bedford , Process Validation Engineer III, Engineering , Bedford, Texas
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