Job Details

Requisition Number 19-0102
Post Date 5/2/2019
Title Sr. Process Engineer
City Orangeburg
State NY
Description Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world.

We have several locations across the US and are looking for new Associates to join our team!


POSITION PURPOSE

The individual will be a key leader within engineering group for managing process engineering activities that include new process development, technology transfer, validation, capital projects for processing equipment and GMP support for processes that support commercial manufacturing. The successful candidate will be a leading contributor during execution of process engineering activities for the department, including troubleshooting problems, analyzing data and optimizing processes.


ESSENTIAL FUNCTIONS AND BASIC DUTIES

1. Leads manufacturing support related work including laboratory and pilot scale studies to support new process development and optimization.
2. Evaluates new generic platform technologies that can be applied across multiple products.
3. Leads tech transfer of multiple programs spanning all phases of product lifecycle, including discussions of scale, equipment design and oversight of formulation batches.
4. Interacts with manufacturing operations staff, troubleshoots problems and supports their operations.
5. Writing, reviewing and approving of user requirement specifications, functional requirement specifications, validation documentation, and master batch sheets
6. Organizational support and cross-functional project team leadership and participation.
7. Responsible to support procuring new processing technologies and processing equipment providing subject matter expertise
8. Manage formulation matrix to evaluate worst case grouping for cleaning validations
9. Support qualification and validation of processing equipment and water system.
10. Manage validation life cycle activities for liquid processing equipment including equipment, process, cleaning validation, and ongoing monitoring
11. Identify, plan and implement process improvement projects in batching processes.
12. Technical support for manufacturing with equipment issues, modifications and additions.


PERFORMANCE MEASUREMENTS
1. Successful and timely completion of engineering projects
2. Successful audit outcomes by internal and external auditors and regulatory agencies
3. Achieve or exceed cost savings targets

Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection product

Requirements QUALIFICATIONS

EDUCATION/CERTIFICATION:
Bachelor’s degree in Engineering; Chemical Engineering preferred

REQUIRED KNOWLEDGE:
-Proficient in Microsoft Word, Excel, PowerPoint, Mini-Tab (or equivalent)
-Working knowledge of formulation tech transfer and scale up
-Familiar with design controls, Good Engineering Practices; FDA and ISO regulations (cosmetics, drug, and medical device), and GMP practices

EXPERIENCE REQUIRED:
10+ years of experience in a manufacturing/regulated environment managing complex process engineering projects; New formulation scale up and technology transfer experience

SKILLS/ABILITIES:
-Excellent verbal and written communication skills
-Skilled in technical project management.
-Excellent problem solving and interpersonal skills.
-Proven ability to work in a fast paced environment with demonstrated capacity to juggle multiple competing tasks and prioritize accordingly to meet program timelines.
-Use of extensive project leadership experience to drive the planning and management of risks, priorities and contingencies.


WORKING CONDITIONS

NONE: No hazardous or significantly unpleasant conditions.


INTENT AND FUNCTION OF JOB DESCRIPTIONS

Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions. Well-constructed job descriptions are an integral part of any effective compensation system.

All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate.

In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.

Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.
  • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
  • Please view Equal Employment Opportunity Posters provided by OFCCP here.
  • The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
  • Please refer to the Company’s Substance Abuse Policy which protects the safety and well-being of all associates and potential associates.
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