Pfizer Reliability Engineer Drug Product Supply in Groton, Connecticut
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The successful candidate will be responsible for the upkeep and management of standard and novel pharmaceutical equipment associated with the manufacture of solid dosage forms. The candidate will be required to provide a wide variety of equipment focused support activities which includes; Equipment Lifecycle Management (IQ/OQ/PQ support, IOQ protocols, Periodic Reviews and associated change controls), establish and optimize an Operator Care program initially focused on continuous manufacturing process streams (followed by batch processing equipment), support and manage equipment reliability strategy through the support and managing of change parts / wear parts and consumables. Additionally, the candidate will support the setup of advanced manufacturing equipment, perform first response assessment on equipment issues, determine corrective action, support automation and controls, and support the training of Operators and SDM colleagues.
The successful candidate will report into the Technical Support (Engineering Group) in the Groton SDM. The candidate will work closely with a wide variety of manufacturing vendors and internal colleagues/groups to ensure pharmaceutical equipment associated with the manufacture of solid dosage forms is operational, with a specific focus on minimizing equipment downtime.
Demonstration of teamwork within the operation unit when interfacing with a wide variety of support groups is a requirement.
Accountable for maintenance and reliability engineering activities involving the redesign, maintenance, and repair of production and non-production equipment via one or more of the following trades: electrical, general maintenance, setting priorities and forecasting and allocating resources needed to complete all preventive and corrective maintenance tasks.
Perform activities on production machinery such as: set up, adjust, repair, maintain, change tooling, strip and clean equipment, diagnosis and repair minor local electrical / mechanical problems, perform preventative, predictive and corrective maintenance, performs specification checks. Interprets blueprints, sketches, and engineering specifications; determines sequence of operations and method of setup; uses a variety tools and precision measuring instruments; makes computations relating to dimensions of work, tooling, feeds, and speeds; measures, marks, and scribes dimensions and reference points; fits and assembles precision parts into mechanical equipment and determines material, parts, and equipment required.
• Support solid dosage manufacture Equipment Qualification (IQ/OQ/PQ)
• Responsible for solid dosage manufacturing Equipment Lifecycle Management (Periodic Reviews and Change-Controls)
• Responsible for assisting with Factory Acceptance testing, Site Acceptance testing, Qualification and Validation support for new novel manufacturing equipment.
• Support equipment/process repairs associated with the manufacture of SDM forms.
• Responsible to provide "hands-on" training for GRO-SDM Manufacturing Technicians.
• Create and manage equipment reliability tools such as Operator Care Programs and use of predictive maintenance techniques.
• Create and maintain a database for spare and replacement part inventories
• Manage replacement parts and schedule vendor support (when needed)
• Coordinate and complete the required PM/Cal activities for the process rooms and equipment with the associated groups (Tech Support, GPO, SDM Scheduler).
• Focus on providing immediate troubleshooting / manufacturing support during manufacturing operations.
• Direct oversight of process equipment set-up and the management of associated tooling and change parts.
• Ensure all operations are executed according to Pfizer and OSHA safety standards.
• Responsible for contributing to departmental technical/GMP/safety training
• Responsible for identifying and resolving quality concerns and contributing to the subsequent investigational reports within the quality system (QTS).
• Responsible for providing detailed reports to SDM and development teams.
Associate in Science degree in Manufacturing Engineering along with 5+ years of pharmaceutical industry experience with increasing responsibility.
Focus areas should include solid drug product manufacturing and/or pharmaceutical equipment maintenance/repair. A strong knowledge of computer automation, current GMP's,
Equipment reliability strategies and understanding of SDM unit operations is required.
Knowledge of scale-up/technical transfer is desirable. Excellent planning and organizational skills and demonstrated skills in team matrix working environment are also desirable. Strong interpersonal, organizational and communication skills (both oral and written) are a must.
Standing, bending, climbing, reaching and lifting upward of 55 pounds may be required. Personal Protective Equipment such as gloves, a full Tyvek suit and breathable air or filtering face piece may be required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This is primarily a 1st shift position with extended hours, off-shifts and weekends. Occasionally travel is expected (5%).
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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Additional Offer Details:
Additional Location Information : Groton, CT
Eligible for Employee Referral Bonus
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.