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 Manufacturing Training Specialist
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Emergent BioSolutions

Job Code Number

3914400

Job Description

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Req ID: 1955
Description:
Design and conduct Manufacturing Technician on-boarding, orientation and training program including commercial and non-commercial operations, Formulation, Inspection and Packaging.Responsible for implementation and communication of complex compliance and process related activities (i.e. regulatory commitments, continuous improvement initiatives, etc.) as they relate to training and education of floor-level Manufacturing staff.

Responsibilites


Develop, coordinate and present department-wide classroom training on process improvement initiatives and Manufacturing core job related topics, including but not limited to:

-Compliance and regulations

-Aseptic media qualification

-Critical Utilities

-Contamination Control

-Shutdown and start-up

-Corrective and Preventive Actions (CAPA)

-Equipment operation

Certified as Qualified Trainer and educates Manufacturing staff on Manufacturing process fundamentals and execution including, but not limited to:

-The underlying basis of processes (the ‘whys’ and “how they work”)

-Thorough understanding of Quality by Design (QbD) principles.

-How techniques are to be performed (and why), with skill-based assessment and re-qualification

Coordinate training and progression plan for Assistant and Technician level employees

-Accountable for maintaining documentation of training progress through the Learning Management System (LMS) and through tracking of Technique Driven skill assessment learning.

-Accountable for the competence of the trainee

Coordinate and perform cross-functional internal audits of all commercial and non-commercial manufacturing facilities:

-Author and generate report detailing results of all audit activities

-Initiate any corrective and preventive actions resulting from audit execution

-Apply corrective and preventive actions globally when applicable

Participate in cross-functional meetings as the Manufacturing point of contact for the development and implementation of corrective actions to deviations and regulatory inspections

Collaborate with Manufacturing and support departments to determine operational viability of complex initiatives prior to implementation

-Communicate strategy and rationale to Technician level employees

-Solicit feedback and suggestions from all Technician level employees for incorporation into the planning process for the initiative.

-Create and collaborate on Standard Operating Procedures, Batch Production Records, and other process-related documentation

-Position may be 1st shift (8:00 am - 5:00 pm) or 2nd shift (3:00 pm - 12:00 am)

Behavioral and Cultural Responsibilities

Training

-Adaptable to the learning style of the trainee

-Situational Leadership II competence

-Provide timely and candid performance feedback

-Patience, enthusiasm, thoroughness

-Actively participates in department meetings

-Recognizes positive and detracting behavior on the manufacturing floor and across departments and acts accordingly

-Able to clearly communicate department goals and objectives to incoming Manufacturing Technicians

-Follows through on commitments

-Respects the contributions of others and communicates support for department decisions

-Adaptability – Maintains positive attitude in a changing work environment

-Initiative and creativity – Proactively seeks opportunities to add positive value

-Able to take complex concepts and develop / present material to manufacturing technicians and support groups

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.


Additional Requirements:

Education, Experience & Skills

-BS degree in related field

-Minimum 4 years of relevant experience working in a cGMP environment

-Knowledge of cGMP and CFR requirements

-Demonstrated knowledge of all aspects of the manufacturing process(es) including:

-Process execution

-Process validation

-Cleaning validation

-Proficiency in SAP modules (work requests, Quality Notification (QN) initiation, Document Management System)

-Excellent oral and written communication

-Experience with training/adult learning preferred

Physical/Mental Requirements

Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, lift/carry 50lbs, pull 50lbs

Use phone, copier, and computer. Work in multiple locations and restricted access laboratory environment.

Organize/coordinate, analyze/interpret, problem-solve, make decisions, supervise, plan, communicate and prepare written communications.



How to Apply

Please submit a cover letter and resume at: http://tinyurl.com/a8r8urt

Job Summary