Senior Technical Operations Engineer

AbbVie Inc; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

A leading biopharmaceutical company seeks a Technical Subject Matter Expert responsible for manufacturing support of clinical and commercial API processes. The role involves process optimization, troubleshooting, and regulatory support, requiring technical expertise in chemistry and biochemistry. The ideal candidate will have a strong background in process development with excellent problem-solving and communication skills.

Qualifications

• 4-8 years experience with a Bachelor's degree, 2-6 years with a Master's, or 0-4 years with a PhD in technical experience.
• Knowledge of cGMP and regulatory requirements preferred.
• Experience with new product introductions to commercial facilities preferred.

Responsibilities

• Support facility start-up and assist in equipment validation.
• Provide training and coaching to team and manufacturing personnel.
• Authors technical reports, SOP's, and investigations.

Skills

Problem Solving

Process Development

Technical Writing

Communication

Team Collaboration

Education

Bachelors/Masters/PhD in Chemistry, Biochemistry or Pharmaceutical Sciences

Job description

Responsible for manufacturing support of clinical and commercial API processes.

Technical subject matter expert for all manufacturing and chemistry related issues. Provides rapid response to operational issues and supports ongoing operations including new product introduction, process optimization, monitoring and cleaning. Knowledge of common API analytical techniques and lab work for confirming process chemistry and material qualification. Provides training and coaching to team and manufacturing personnel.

• Support facility start-up and assist in plant equipment and facility validation and qualification activities
• Supports manufacturing activities during the technology transfer, qualification and validation batches associated with new product introductions to the site
• Supports operational efficiency goals for yield, product quality and other product and/or site KPI's
• Contact and consultant for process/equipment troubleshooting and investigation activities
• Actively promotes a culture of GMP and EHS compliance with all applicable policies and guidelines and supports risk assessment activities providing relevant technical knowledge
• Provides support to regulatory filings and audit activities
• Provides support for process cleaning/changeover strategies (CIP/SIP), media/solution preparation and benchtop analytics as required
• Authors technical reports, batch records, SOP's, investigations, protocols as required and ensures consistency and quality of the group's documentation
• Any other responsibilities or tasks as assigned
• Bachelors/Masters/PhDs degree In a technical/science field, including Chemistry, Biochemistry or Pharmaceutical Sciences
• 4-8+ years (bachelor) / 2-6+ years (Master) / 0-4+ years (PhD) technical experience in process chemistry, pharmaceutical manufacturing process, tech transfer, commissioning and validation in pharmaceutical industry.
• Knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is preferred
• Demonstrated process development skills, including the ability to deliver innovative process chemistry at scale. Proven scale up skills, to facilitate the successful transition from laboratory to full scale production.
• Experience of start-ups and new product introduction to commercial facilities is preferred.
• Good problem solving skills, embrace problem solving tools like FMEA, 5 Why, able to work under pressure and tight timeline.
• Team player, highly self-motivated and able to work under minimum supervision.
• Good command in oral and technical writing in English, and excellent communication and presentation skills.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.

About the company

AbbVie is an American publicly traded biopharmaceutical company founded in 2013.

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