Senior Process Engineer

The Position

Support operation team to ensure the operation performance achieve the target with the right procedure by providing technical expertise and execution on process validation, cleaning validation, change control, quality risk management, technical specification on material and component, and new product or line extension market, projects, continuous improvement activities.

Support and/or supervise Operation team on investigation of any atypical or deviation in the product, process or equipment, material and component and develop operational team by training as per requirement to support the technical operation activities.

Responsibilities:

Execute process validation, cleaning validation, environment monitoring, and equipment qualification by preparing, executing, reporting these activities including its periodic monitoring and its documentation.

Involve in tooling/engineering trials, installation, commissioning, and validation activities as required.

Responds to customer needs in a timely and efficient manner. Liaise, coordinate, and communicate with others to effectively meet business needs.

Execute change control process both internal and external site including change from supplier.

Support and/or supervise operation team on investigation of any atypical or deviation result related to technical that happened in the product, process, equipment, material, or component.

Participating in continuous improvement program and project or site objective as required.

Support and execute transfer technology, new product, and extension market implementation.

Maintain technical specification of material and component including creation, revision, or deletion.

Support or supervise on troubleshoot/problem solving in manufacturing and packaging process as required.

Support or assist activities in term of technical perspective for both IPT

Proactively support Permanent Inspection Readiness and support QMS program.

Cultivate strong strategic interpersonal relations within and across function and other colleagues at other sites.

Required Education, Experience, and Skills:

Bachelor’s degree preferably in chemical engineering or Pharmaceutical Technology (other scientific/engineering also accepted)

Minimum 8 years’ experience at process engineer field in pharmaceutical company (manufacturing and packaging).

Proven experience on problem solving related process/product.

Fluent in both written and spoken English.

Oral and written communication skills

Rapidly acquires proficiency in emerging technologies and adeptly disseminates knowledge.

Good level of knowledge of cGMP and regulatory inspections

Results driven person who displaying high integrity and honesty.

Has problem solving, decision-making, and teamwork skills.

Ability to lead, motivate and train others

Passionate for continuous learning and capacity to drive change.

Comprehensive knowledge of the key concepts, principles, methods, and tools related

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

Search Firm Representatives Please Read Carefully

Organon LLC, 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.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status: Regular

Relocation:No relocation

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings: 1

R533284