Project Lead, Maintenance - 1st Shift

Columbus, OH, United States

Job Title: Project Lead, Maintenance

Location: Columbus, OH

Job Type: Full-Time

Job Type: Full-Time, 1st Shift

Req ID: 6334

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Project Lead, Maintenance to join our team.

In this role, you will be responsible to Coordinate and communicate effectively with cross-functional teams, including project managers, production engineers, and technicians.

Lead Continuous Improvement (CI) through packaging process/material optimization (Life-Cycle Management) and the implementation of innovative new technologies/materials.

Provide service and technical leadership, coordinate work activities, and establish priorities within a team to ensure customer service needs are met for the manufacturing, site and/or packaging equipment. Review work of other PRT/MRT's and provide feedback to performance. Ensure reliable manufacturing, packaging, and/or site facility equipment by troubleshooting, adjusting, repairing, rebuilding, fabricating, predicting failures, and replacing components and coordinating vendor support to ensure equipment performance is reliable and meets expectations with root cause analysis of failures with support from Engineer and/or Optimizer. Perform preventive, corrective, or emergency work orders and respond to service calls while the plant is in operation, which may include off-shift periods and weekends. Actively participate in, and sometimes leads, equipment FATs to support production engineering efforts and support installation and training of new equipment to the facility.

Key Responsibilities

Represents Packaging Engineering Lifecycle Operations in the development and filing of new products, as needed, and collaborates with development partners (e.g. Technical Services) during commercialization batch production.

Develops packaging material specifications for new or improved packaging components with input from senior Packaging Engineers.

Prepares line trial protocols/reports, packaging material specifications, SAP master data, master packaging specifications, defines technical elements for product labeling, and complete other documents for assigned products/projects to meet established project timelines under the oversight of senior Packaging Engineers and management.

Writes line trial reports that document technical packaging knowledge in a way that facilitates future decision-making regarding process optimization or troubleshooting (e.g. by Flow operations and/or Technical Flow); guidance from functional management and/or senior Packaging Engineers may be required to address significant process or equipment deviations (e.g. issues that may impact completion of the line trial or require commitment to post-line trial optimization activities or post-line trial monitoring).

Provides review of new products / packaging regarding fit with operational capabilities (e.g. ability of components to run on a particular line, etc.), independently for processes of low to medium complexity (e.g. low complexity may be standard packaging components - bottle, cap, desiccant, cotton; medium complexity may be new components, new tooling, international Brand), and in consultation with senior Packaging Engineers and / or functional management for complex processes (e.g. powder filling, nasal sprays, cold chain], or processes with approaches rarely used (such as controlled atmosphere such as low relative humidity, glass vials, patches).

Creates and reviews documentation (e.g. SAP Master Data, technical data, component specifications, Master Packaging Specification, eForms, technical elements for product labeling) for line trial and launch batch production, based on development packaging design parameters and product requirement considerations, in collaboration with development partners and senior Packaging Engineers.

Ensures attention to detail to documentation to ensure quality and timeliness of documents.

Collaborates with Purchasing and senior Packaging Engineers to source improved packaging components, if needed.

If necessary, escalates to senior Packaging Engineers to analyze the data and determine path forward.

Provides technical support to production, including assessment of non-standard events, implementation of troubleshooting next steps, and determination of product / packaging impact; provides recommendations for scenarios of low to medium complexity and business impact, and with moderate support from development partners, functional management, and/or senior Packaging Engineers for complex scenarios. Support will be required off-shift, including weekends, from time-to-time.

Identifies product / packaging quality and packaging robustness optimization opportunities through analysis of product / packaging performance and collaboration with peer and customer groups (e.g. Physical Flow, Equipment Engineers, senior Packaging Engineers, PD, and QAI). Collaborates with organizational partners to support these initiatives, as necessary.

Collects and analyzes Physical Flow packaging data. Evaluates trends and collaborate with Flow peers and management to identify and propose process improvements.

After consultation with senior Packaging Engineers and management, collaborates with Drug Regulatory Affairs (DRA) to support assessment of the regulatory impact of potential packaging changes, documentation of implemented packaging changes, and ensure regulatory compliance.

Collaborates with Change Management to support packaging and packaging component changes (e.g. CMU process).

Shares and learns from best practices across the organization (PCs, Packaging Engineering Forums, etc.); shares observations from data reviews, highlight common errors, identify potential solutions to common errors, etc.

Meets cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.

Qualifications:

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: High school diploma or equivalent.

Certification / degree from an accredited organization / society / university or subject matter expert on critical equipment.

Minimum 8 years' experience with extensive maintenance of industrial equipment; including, but not limited to manufacturing, packaging and/or site facility equipment.

5 years of experience with equipment start-up and project support.

What We Offer*: Annual performance bonus, commission, and share potential

Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute

A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries

3 personal days (prorated based on hire date)

11 company paid holidays

Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits

Employee discount program

Wellbeing rewards program

Safety and Quality is a top organizational priority

Career advancement and growth opportunities

Tuition reimbursement

Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Agency Notice:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

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