West Pharma Sr Manager Process Validation 

United States, Arizona, Scottsdale 

418520345

JOB SUMMARY

This role is responsible for contributing to the development and implementation of the validation engineering strategy for West Global Technical Operations whilst ensuring the qualification and validation of equipment, facilities, utilities, automated systems, processes and process cleaning procedures are carried out in accordance to GMP and relevant guidelines. This role will direct the application of resources within and across its functional responsibility to assist global sites in improving the manufacturing of products and develop the most optimum processes and solutions which meet or exceed West and/or customer requirements.

Responsible for the Process validation of all new or upgraded manufacturing equipment

Provides direction on strategic vision as well as long-term and intermediate goals the Global Technical Operations Network.

Provides technical engineering expertise and guidance when needed to ensure optimization of manufacturing equipment and processes

Participates in the harmonization and implementation of Validation standards and procedures across the Global Technical Operations network based on current regulations, industry standards and industry practices.

Drives innovative, continuous improvement and efficient approaches to validation incorporating science and risk-based approach.

Leads and fosters an environment of continuous improvement and providing leadership in this area by identifying and implementing lean, efficiency, cost reduction, quality, and service level improvements

Oversees the preparation, review, and approval of Site Validation Master Plans.

Implements lean processes, KPI metric analysis and best practice strategies to drive best practices throughout manufacturing operations

Reviews and/or approves qualification and/or validation documentation (specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation.

Oversees third party generated protocols and reports in conjunction with program Quality representation.

BASIC QUALIFICATIONS

Master's Degree

In Engineering or technical degree

Minimum 10 years (Sr Mgr)

10 years of Process / technical work experience

Lean Six Sigma training

cGMP knowledge

Ability to manage projects from conception to production

Effectively use software tools to manage timelines and budgets

Self-motivated and solution-oriented personality.

Excellent communication and interpersonal skills.

Good organizational skills.

Effective problem-solving skills.

Ability/courage to successfully communicate with any required parties.

• Compliance to all local environmental, health & safety regulations.

• Compliance to all local site company policies, procedures & corporate policies

Financial Analysis and Reporting experience

5+ years of practical Process/ Ops related implementation experience in a manufacturing / production environment.

exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.