Senior Process Engineer
Company: Pfizer
Location: Rocky Mount
Posted on: May 14, 2022
Job Description:
Why Patients Need YouWhether you are involved in the design and
development of manufacturing processes for products or supporting
maintenance and reliability, engineering is vital to making sure
customers and patients have the medicines they need, when they need
them. Working with our innovative engineering team, you'll help
bring medicines to the world even faster by imagining what's
possible and taking action.What You Will AchieveThe Sr. Process
Engineer is primarily responsible for executing projects planned by
Process Engineering. This individual ensures all Process
Engineering documentation deliverables are generated, and may be
asked to develop new processes or optimize existing ones. This
individual may lead large scale projects; as well as, coordinate
all work including but not limited to coordination of personnel
activities, documentation and outside resources. The Sr. Process
Engineer will develop and manage project scopes for contractors and
consultants in the support of project and process
implementation.The Sr. Process Engineer supports manufacturing
processes and operations at the Rocky Mount, NC facility. Work
includes but is not limited to supporting identification and
implementation of process improvements, system design, capital
project support, and investigation support. Individual ensures all
Process Engineering documentation deliverables are generated, is
expected to develop new processes and/or optimize existing ones.
This individual may lead large scale projects; as well as,
coordinate all work including but not limited to coordination of
personnel activities, documentation and outside resources. The Sr.
Process Engineer will be required to develop and manage project
scopes for contractors and consultants in the support of project
and process implementation.The Sr. Process Engineer is expected to
support a broad range of equipment and processes. Employee will be
working within a sterile injectable facility, which may include
working within clean rooms. Equipment and processes may include
packaging/automated visual inspection processes, Formulation
systems, CIP/SIP skids, commodity prep, washing, filling, capping
and/or sterilization (to include dry heat ovens/tunnels and
autoclaves) processes for a broad range of products and product
configurations. Engineer will be expected to work with
corresponding teams (automation, maintenance, ops, validation,
quality functions) at the site to understand, implement and improve
processes. Engineer is expected to understand the overall process
sequences beyond individual equipment and impact on product
quality.How You Will Achieve It
- SME for critical process operations within formulation and
filling operations.
- Expected to have strong process/mechanical/controls knowledge
of key process equipment to include commodity washers,
depyrogenation tunnels, autoclaves, fillers, cappers, vision
systems, CIP/SIP processes and formulation systems such as mixing
tanks.
- Individual must have project management skills, knowledge and
application experience of technical design reviews, commissioning
and validation for pharmaceutical processes.
- Individual will be expected to work routinely with cross
functional groups throughout the site for process improvements and
implementation.
- Must have a solid understanding and knowledge of pharma
regulations and cGMP principals and demonstrated ability to apply
knowledge to process improvements and changes. Responsible for
interfacing with auditors and presenting on site processes.
- Responsible for leading and/or supporting root cause analysis
and developing engineering resolutions for corrective actions.
- Troubleshoots production related equipment/process issues.
- Organizes, oversees and analyzes testing associated with the
development of new process technologies and the support of new
product introductions and tech transfers.
- Works closely with Corporate R&D and technical services to
develop and confirm Critical and Key Process Parameters equipment
and processes to ensure acceptable quality.
- Plans, reviews and approves engineering studies for engineering
cycle development and research. Leads FAT (factory acceptance
testing) and ensures protocol execution is per plan.
- Supports installation, operational, and performance
qualification activities. Direct the work of other process
engineers and contract engineering resources, to include
performance evaluations for Pfizer direct reports.
- Expected to establish methods for ongoing monitoring/trending
of process/mechanical issues. Responsible for review and approval
of site documents to include calibration reports, batch records,
SOP's, change control, and design specs.QualificationsMust-Have
- Bachelor's Degree in an Engineering or related discipline with
a minimum of 3 years of engineering experience is required.
- Understanding of mechanical design, electro mechanical, and
automation controls is required.
- Excellent communication and presentation skills and attention
to details are required.
- Strong technical writing and presentation skills are
required.Nice-to-Have
- Pharmaceutical industry and GMP experience is preferred.
- Knowledge/understanding of global regulations for drugs is
preferred.PHYSICAL/MENTAL REQUIREMENTS
- Able to stand for extended hours for test runs and performance
monitoring of processes - will include working within special
gowning for area access
- Able to climb ladders/steps
- Able to lift items of 25lbs
- Capable of data analysis using statistical tools/graphing
- Strategic thinker for issue resolutionNON-STANDARD WORK
SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Pfizer operates 24/7
across most of the business units. Employee must have the ability
to work extended hours, holidays and/or weekends as needed. Limited
travel may be required to support OEM equipment design reviews
and/or Factory Acceptance Testing of new equipment.Other Job
Details:
- Eligible for Relocation Package
- Eligible for Employee Referral BonusPfizer requires all U.S.
new hires to be fully vaccinated for COVID-19 prior to the first
date of employment. As required by applicable law, Pfizer will
consider requests for Reasonable Accommodations.Sunshine ActPfizer
reports payments and other transfers of value to health care
providers as required by federal and state transparency laws and
implementing regulations. These laws and regulations require Pfizer
to provide government agencies with information such as a health
care provider's name, address and the type of payments or other
value received, generally for public disclosure. Subject to further
legal review and statutory or regulatory clarification, which
Pfizer intends to pursue, reimbursement of recruiting expenses for
licensed physicians may constitute a reportable transfer of value
under the federal transparency law commonly known as the Sunshine
Act. Therefore, if you are a licensed physician who incurs
recruiting expenses as a result of interviewing with Pfizer that we
pay or reimburse, your name, address and the amount of payments
made currently will be reported to the government. If you have
questions regarding this matter, please do not hesitate to contact
your Talent Acquisition representative.EEO & Employment
EligibilityPfizer 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.Engineering
Keywords: Pfizer, Rocky Mount , Senior Process Engineer, Other , Rocky Mount, North Carolina
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