Senior Process Engineer
Company: Pfizer Inc.
Location: Rocky Mount
Posted on: November 9, 2019
The Sr. Process Engineer is expected to serve as an SME for core
operational areas related to finishing and packaging operations for
a dynamic, 24/7 manufacturing operations. Key equipment will
include Labelers, cartoners, bundlers, vision systems, automated
visual inspection, leak detection and serialization equipment for
processing of small volume parenterals. Identifies, supports
projects executed by multiple functions including planning and
scheduling all activities to achieve the desired results. Supports
development and management of project scopes for contractors and
consultants in the support of project and process implementation.
S/he supports the development of project schedules and coordinates
applicable work to meet the deadlines in the Plant Capital Plan,
New Product Introductions, and New Process Technology Developments.
Ensures all project documentation is generated per the schedule,
executed on time and that it is complete and accurate. S/he leads
the development of new processes and optimization of existing
- Acts as the SME for critical process operations within
finishing operations. Expected to have strong
process/mechanical/controls knowledge of key process equipment to
include labelers, cartoners, bundlers, vision systems, automated
visual inspection, leak detection and serialization equipment.
- 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
- Must have a solid understanding and knowledge of pharma
regulations and cGMP principals and demonstrated ability to apply
knowledge to process improvements and changes. Will be responsible
for interfacing with auditors and presenting on site
- 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
- Will direct the work of other process engineers and contract
engineering resources, to include performance evaluations for
Pfizer direct reports.
- Will be 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.
- Bachelor's Degree in an Engineering field or similar discipline
with a minimum of 3 years of relevant experience is required, or a
Master's Degree in an Engineering field or similar discipline with
1 year of relevant experience is required.
- Knowledge/understanding of commissioning and qualification
- Excellent communication and presentation skills and attention
- Strong technical writing and presentation skills
- 3 years of pharmaceutical industry experience is preferred
- Knowledge/understanding of global regulations for drugs
- Understanding of mechanical design, electro mechanical, and
- Experience with serialization is preferred
- 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 resolution
NON-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.
Pfizer 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 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.
OTHER JOB DETAILS
- Last Date to Apply for Job: 11/11/19
- Eligible for Relocation Package
- Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all
applicable equal employment opportunity legislation in each
jurisdiction in which it operates.
Keywords: Pfizer Inc., Rocky Mount , Senior Process Engineer, Other , Rocky Mount, North Carolina
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