Process Engineer

Why Patients Need You
Whether 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 Achieve
The Process Engineer is 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 will support large scale projects; as well as coordinate all work including but not limited to coordination of personnel activities, documentation and outside resources. The Process Engineer will develop and manage project scopes for contractors and consultants in the support of project and process implementation. The Process Engineer supports daily manufacturing processes by troubleshooting equipment or process issues, investigational analysis, and/or continuous improvement/corrective action initiatives. Supports Data Integrity (DI) initiatives and maintenance of DI compliance associated with manufacturing processes and controls.
How You Will Achieve It

• Executes projects assigned by Process Engineering Manager or Engineering Lead.
• Coordinates all work on scheduled projects needed to meet the deadlines developed by Plant Capital Plan, New Product Introductions, and New Process Technology Developments.
• Responsible for manufacturing engineering support, the development of new process technologies, and the support of new product introductions/tech transfers.
• Organizes testing associated with the development of new process technologies and the support of new product introductions/tech transfers.
• Works closely with site tech. services to develop and confirm Critical and Key Process Parameters needed for Equipment and processes. Develops and delivers presentations to communicate project timelines and milestone completions.
• Contribute to Project Technical Teams, communicate and collaborate effectively to ensure effective interactions with all stakeholder groups.
• Design technical/engineering studies, writes technical reports summarizing study results and generates necessary data to support process development for new equipment, process changes, commodity changes and/or investigation/CAPA support.
• Generate/Support site technical assessments (i.e., alarm, risk, engineering).
• Completes change management and implementation for changes to the manufacturing processes and associated systems.
• Support new technologies at the site.
• Develops and supports qualification of manufacturing processes for drug products, taking into consideration problems inherent in processes & technology.
• Supports deviations that occur on the manufacturing floor as well as root-cause analysis and identifies appropriate, effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups, i.e. engineering, maintenance, quality, validation, operations, EHS, etc.
• Supports technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization.
• Collaborates with other enabling departments (Quality, Engineering, Maintenance, etc.) to assure initiatives are successful.
• Person will be responsible for interfacing with auditors and presenting on site processes. Support assurance that data integrity practices and procedures are implemented on all systems in Manufacturing for quality compliance and to meet industry standards.

Qualifications
Must-Have

• Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience to the job role OR an Associate's degree with 4 years of experience OR a Bachelor's degree with 0 years of experience.
• Proficient in Microsoft Word, Excel and PowerPoint.
• Knowledge of cGMP, safety and environmental regulatory requirements.
• Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.
• Must be self-motivated and work with minimum direction
• Good interpersonal effectiveness and communication skills (written and oral) are required in order to interface across cross functional teams, both technical and non-technical.
• Pharmaceutical or manufacturing experience and strong, demonstrated technical skills exhibited in a cGMP environment are requirements. Specific knowledge of and experience withDrug Product processing and equipment is highly desirable.
• An aptitude for understanding process technology and equipment, decision making ability, and excellent oral and written communication skills are essential. Candidate must possess flexibility to respond to changing conditions and priorities.
• Understanding of automation systems/applications a plus.

Nice-to-Have

• 2-5 years in pharmaceutical industry engineering preferred.
• Manufacturing experience with demonstrated technical skills related to pharmaceutical processes are highly desired. Preference of experience with sterilization processes: equipment, component and final product.
• Understanding of global regulations on data integrity and FDA 21 CFR Part 11 requirements
• Understanding of basic manufacturing processes and data recorded both electronically and on paper records.

Physical / Mental requirements

• Remains organized & positive in ambiguous and fast-paced, rapidly changing environment
• Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure.
• Ability to process complex information and make recommendations with incomplete data set
• Ability to adjust work schedule to meet business needs - overtime, off shift, weekends.
• Ability to travel- travel time may be up to 20% according to business needs.
• Able to stand for extended hours for test runs and performance monitoring of processes - will include working within special gowning for cleanroom 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

• 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

• Last day to Apply: Feb 27th, 2025
• Eligible for Relocation Assistance: Yes
• Referral Bonus eligible
• Work Location Assignment: On Premise

The annual base salary for this position ranges from $66,500.00 to $110,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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. This position requires permanent work authorization in the United States.
Engineering