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Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Job Description

Location

Sellersville

Band/Grade:

2A

Department

Packaging Operations

FLSA

Exempt

Sub Function

Last updated

07/15/2024

Provides technical oversight, improvements, troubleshooting, support, and project leadership in the Sellersville Manufacturing Packaging area.

Manager

Director Engineering

Key Stakeholders

External

Internal

Packaging equipment and component vendors

Maintenance, Engineering, Supply Chain, Quality Assurance, Global Serialization, Packaging Technology, Packaging Manager, Packaging Techs

Essential Duties and Responsibilities

• Provides packaging engineering, packaging equipment and packaging component expertise to improve costs, efficiencies, and meets production targets
• Serves as the subject matter expert (SME) for serialization for the SLV Packaging line by creating recipes, testing and validating global serialization programs
• Partners with Operations Excellence to implement various lean improvement techniques to improve the OEE
• Helps trouble-shoot equipment and processes as well as improvement projects
• Proposes, designs and manages various Packaging capex projects
• Leads individual and team efforts for quality investigational events using a lean methodology (cause and effect diagrams, SIPOC, 5Y's etc.) to reduce quality defects produced on the packaging line
• Initiates, writes and executes validation protocols following applicable cGMP and SOPs
• Supports development of new packaging components and integrated closure systems
• Reviews and approves packaging material and component specifications
• Conducts RCA of any packaging component related complaints
• Support QA and RA teams on technical reports and documentation needed to support any quality investigations and regulatory submissions
• Develops and implements operator training
• Writes and executes packaging studies, validation protocols, SOPs and training plans
• Initiates projects that will increase packaging output (bottles) on packaging line and improvement to processes
• Other duties as required
  

Key Competencies (knowledge, skills, and abilities every person must possess to be successful)

• Strong mechanical aptitude
• Excellent verbal and written communication skills
• Creative and able to present various solutions
• Understanding process improvement, quality improvement concepts
• Understanding of DMF requirements for filing in a global market
• Energetic, enthusiastic, and motivational disposition
• Ability to work independently and as a part of a team
• Effective problem solving and decision-making skills
• Ability to multi-task being able to manage multiple projects simultaneously

Education/Experience

• Bachelor's degree or relevant equivalent experience
• Must have 5+ years' experience in packaging engineering or packaging development
• Proficiency in 3D CAD Software; Solidworks, AutoCad, etc.

Physical Demands:

Physical Effort (Occurrence frequency for each activity)

Activity

N/A

Occasionally

Frequently

Continuously

Sitting/Standing/Walking

Balancing/ Kneeling/Crouching/Stooping

Crawling/Climbing

Reaching/Working Overhead

Keyboard Use/Repetitive Hand Motion

Pushing/Pulling (up to 25 pounds)

Lifting/Carrying (up to 25 pounds)

Reporting to this position: 0

General Oversight and Direction:

Receives moderate to limited supervision working from objectives set by Manager. Employee organizes and carries out most assignments in accordance with standard practices, instructions, or previous training. Employee handles some situations independently.

Equal Employment Opportunity

Piramal Critical Care is committed to Equal Employment Opportunity. It is the policy of the Company to encourage and support equal employment opportunity for all associates and applicants without regard to age, sex, race, color, ancestry, religious creed, national origin, pregnancy, physical or mental disability, medical condition, marital status, political affiliation, sexual orientation, disabled veteran, or Vietnam Era Veteran Status.

Americans with Disabilities Act

Applicants as well as employees who are, or become, disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.

Employee Job Responsibilities

You are expected to follow all policies, procedures, and guidelines, conducting yourself in ways that protect the interests and safety of all employees and the company.

The above statements reflect the general duties and responsibilities considered necessary to perform the essential functions of the job. This document should not be considered a fully detailed description of all the work requirements of the position. Piramal Critical Care may change the specific job duties with or without prior notice based on the needs of the organization.