JO-4206

Quality Search  -  Since 1981

Position Title:

Packaging Engineer III or a Senior Packaging Engineer

Location:

West Coast

Experience:

8 or more years

Specialty:

Biopharmaceuticals

Salary Range:

$90-125K

Bonus Range:

9%

Education:

B.S. Degree in Packaging or equivalent

Travel:

15-20%

Direct Reports:

None initially but later with growth

Relocation:

Yes

Other:

They would like experience with CMO’s and all of the standard forms of pharmaceutical packaging such as blisters, bottles, vials etc.

DESCRIPTION - DUTIES

Company Overview:  This is a biopharmaceutical company focused on the discovery and development of the novel therapeutics for the treatment and prevention diseases. They are dedicated to developing and commercializing therapies that transform patient lives and advance patient care by changing treatment paradigms in thrombosis and other hematologic diseases.


Position:  This position, Packaging Engineer III or Senior Packaging Engineer requires a thorough understanding in the selection and identification of primary, secondary and tertiary package components.  In addition he, or she, will understand materials, and delivery systems for company products and will support key commercial and clinical packaging and labeling operations. This position requires a demonstrated ability in designing packaging specifications, developing packaging batch records, qualifying and validating packaging processes, and resolving technical issues with component suppliers and contractor facilities.  The successful candidate requires thorough knowledge and demonstrated experience in package design and development for distribution cycle and thermal package testing, and an acute understanding of regulatory requirements and industry trends for controlled environment shipments.  This person will work closely with colleagues from the Manufacturing, Supply Chain, Pharmaceutical Development, Quality Assurance, Regulatory Affairs, Project Management, and Marketing groups and staff from other functional areas, to meet complex deliverables such as new product launches or start-up of new manufacturing sites while ensuring an uninterrupted commercial and clinical product supply.  In addition, this individual will participate in the introduction of process improvements, maintain relevant metrics for all packaging projects/operations, trouble-shooting of process-related issues and will support root cause analysis of packaging deviations.  They will also be responsible for managing the process of developing, reviewing, and approving commercial and labeling components.


Responsibilities:

  • Ensure optimal supplier performance and continuity of supply by maintaining strong partnerships with external suppliers of packaging operations, materials, and services for development and commercial products
  • Lead and/or support component design and material selection; source, obtain quotes, and negotiate per desired specifications; evaluate submissions with team and management for approval
  • Support end-to-end packaging validation activities and be responsible for authoring and reviewing packaging qualification and validation documents
  • Collaborate with Pharmaceutical Development, Regulatory, Supply Chain, Quality, and other departments to oversee and meet all packaging technical and operation activities, including but not limited to; regulatory requirement submissions, engineering studies and line qualification, storage and distribution testing and USP Testing, to ensure a robust supply of commercial and clinical product supply to patients
  • Act as the Person-In-Plant (PIP) to provide Company oversight of CMO Packaging and Labeling activities, including line trials, line qualification process validation
  • Ensure packaging solutions are in compliance with international regulations and adherence to relevant quality directives, procedures, guidelines and global standard processes
  • Oversee the Labeling Operations function for developing, reviewing, and approving commercial and clinical labeling; this includes working with and overseeing internal or external staff functions for a Graphic Designer and Technical Editor/Proof-reader
  • Track deviations and process/operational changes; ensure appropriate technical and management visibility within Company to these events and facilitate feedback and decisions to the CMO
  • Lead/support CMO packaging and labeling operations including master batch creation, batch record review and commercial batch disposition
  • Work semi-autonomously on complex tasks or several parallel tasks and projects and met deadlines
  • Undertake measures to achieve project goals in the event of deviations from the project plan, may exercise judgment in selecting methods, techniques and evaluation criteria for obtaining results and works on complex issues where analysis of situations and data requires in-depth knowledge and understanding of the organization
  • Support external quality and global procurement with the selection and qualification of globally relevant suppliers
  • Assess process and activity gaps and propose plans to mitigate; identify and implement new technologies/packaging processes for improved efficiencies and/or cost savings
  • Develop platform solutions anticipating future business needs
  • Provide leadership of best practice and continuous improvement of the Packaging Engineering and Labeling Operations Functions
  • Keep management informed of any significant risks to CMC timelines and/or budgets relating to Packaging and Labeling
  • Travel required: 15-20%

REQUIREMENTS - BACKGROUND

Education:  Requires a Bachelor's degree in Packaging, Mechanical Engineering, or related technological field. 


Experience:  Requires a minimum of 8 or more years of experience in supporting commercial and clinical packaging operations for parenteral drug and both solid and liquid oral dosage forms


Desired Qualifications:

  • Demonstrated leadership in a wide range of packaging related technologies with strong fundamental knowledge of primary and secondary packaging systems & processes, and quality systems
  • Working knowledge of equipment IQ, OQ, and PQ and development of qualification protocols / reports for packaging and shipping qualification activities
  • Expertise in biologic and solid dose packaging disciplines: materials, bottle and closure systems, blister packaging, design of secondary and tertiary components, component compatibility, component qualification, equipment installation and qualification
  • Knowledge of cGMPs and associated regulatory considerations in a commercial and clinical pharmaceutical packaging environment
  • Understanding of the development and maintenance of packaging specifications
  • Knowledge regarding design control, documentation, risk management and processes such as MRD, DIR, FMEA, design verification, and URS
  • A track record of successfully managing multiple projects within a cGMP related environment
  • Ability to manage timelines and prioritize task execution based on business need; problem-solving, solution-driven self-starter
  • Excellent organizational, project management, technical, problem solving and communication (written & verbal) skills
  • Ability to think both strategically and tactically with exceptional attention to detail
  • Demonstrated ability to manage multiple high-priority projects concurrently in an often-changing environment
  • Able to work with a range of technically and culturally diverse people, influencing them to get the job done, and delivering value-added business results that meet high quality requirements within a tight schedule
  • Awareness of resources and best practices across the pharmaceutical packaging industry, and a track record of managing outsourced packaging and labeling operations

Contact us to discuss this opportunity - OR -  Pass this job along to a fellow Packaging Professional

Quality Search, 1820 Graham Drive • Chesterton • IN • 46304-1627 • (219) 926-5015 (HQ) www.qsjobs.com

 

For further details on JO-4206

Inquire through Tony Vesh

Ph:  (219) 926-6831     Bio of Tony Vesh

Inquire through Peter Nye

Ph:  (219) 851-7478     Bio of Peter Nye

Inquire through Doug Scripture

Ph:  (269) 598-1915     Bio of Doug Scripture

Inquire through Jeff Wolfe

Ph:  (219) 926-5015     Bio of Jeff Wolfe

- OR -

 

Inquire through Quality Search

A Recruiter will be assigned to you.

Ph:  (219) 926-7772     Web Site   

We look forward to working with and for you in your career enhancement!



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