Job detail for Specialist Technician - IPT Inactivated Biological Production

Job Description

Specialist Technician - IPT Inactivated Biological Production

POSITION OBJECTIVE:

Provide technical support to the IPT for Inactivated Biological Production to carry out production activities within quality and safety standards, as well as collaborate in the management of generated documentation and the analysis of production data. Lead investigations involving IPT products and implement applicable corrective actions, as well as collaborate and coordinate validations. Propose and lead improvement projects and change controls.

REQUIREMENTS:

Valued qualifications:

Degree in a Biological/Health field and/or at least 1 year of experience in the pharmaceutical industry.

Knowledge of GMP regulations (requirements for aseptic processes and production facilities...).

Experience in audit processes or supporting such processes.

Basic knowledge of production processes in classified rooms.

Knowledge of document management systems (Procedures, Instructions,...) and Regulatory processes.

Knowledge of SAP application.

Knowledge of Reliance application.

Knowledge of LABWARE system.

Knowledge of MEDS system.

Use of support tools such as: e-logs, Meds, Trend...

Advanced knowledge of English.

POSITION FUNCTIONS:

Management of Change Controls and Management of Deviations, CAPAs in Reliance.

Management of improvement projects.

Preparation of investigation reports related to products in the area.

Management of production documentation (Manufacturing Instructions, Technical Work Instructions, Technical Equipment Operating Instructions,)

Collaboration in the management of product transfers to the plant.

Collaboration with production areas (material allocation,...)

Participation in Audits.

Generation and analysis of production data.

Collaboration in achieving plant Key Performance Indicators.

Required Skills:

Adaptability, cGMP Compliance, Data Analysis, Environmental Health and Safety (EHS) Management, Equipment Set Up, Lean Manufacturing Tools, Process Monitoring, Regulatory Compliance, Teamwork, Visual Management

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/2/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.