Chemical Operator

Piramal Pharma Ltd; Riverview (MI); On-site; USD 55,000 - 85,000; Full time

Job summary

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility in Riverview, Michigan, is seeking a Chemical Operator I to join the Production team. The operator conducts chemical syntheses of APIs, their intermediates and other materials in accordance with SOPs, batch records, and cGMP.

Candidates must meet regulatory requirements, maintain safety and quality, and be capable of following procedures, maintaining equipment and documentation, and communicating issues promptly.

Qualifications

• High school diploma or equivalent.
• Two-year diploma from an accredited institution or equivalent experience.
• Prior industrial chemical experience preferred.
• Knowledge of cGMP, OSHA, and EPA regulations.
• Must be able to pass a respirator fit test.

Responsibilities

• Conduct chemical syntheses of APIs and their intermediates.
• Comply with PPS and external regulatory policies.
• Maintain cleanliness of work area and equipment.
• Support inventory control of raw materials and wastes.
• Document work per ASI formats and electronic systems.
• Assist in assembling and maintaining regulatory documents.
• Report needs or problems to Supervisor promptly.

Skills

Mechanical skills

Interpersonal communication

Record-keeping

Regulatory knowledge

Respirator fit test

Education

High school diploma or equivalent

Two-year diploma

Job description

Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Chemical Operator

Job Description

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility located in Riverview, Michigan, is seeking a qualified Chemical Operator I to join our Production team. The Chemical Operator I is responsible for conducting chemical syntheses/manufacture of active pharmaceutical ingredients (APIs), their intermediates and other materials according to applicable SOPs, batch records, and current Good Manufacturing Practices (cGMP).

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:

Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
Identify and protect the original technical information as part of the company property.

KEY RESPONSIBILITIES.

• Conduct chemical syntheses of APIs and their intermediates within scheduled dates or times independently.
• Comply with all applicable policies and procedures. This includes those required by PPS as well as external regulatory bodies.
• Maintain cleanliness and routine maintenance of the work area and equipment items within the working environment.
• Support the control of inventory of basic raw materials, consumables, and wastes within the immediate working environment.
• Document all work conducted according to ASI required format(s). Including but not limited to electronic systems.
• Assist in the assembly and maintenance of documents particular to the operation and complying with applicable regulatory requirements.
• Recognize and report needs, concerns, and or problems to Supervisor in a timely manner.

EDUCATION/EXPERIENCE.

• High school diploma or equivalent.
  • Two (2) year diploma from an accredited institution or equivalent experience strongly preferred.
• Prior industrial chemical experience highly preferred.

JOB COMPETENCIES.

• Mechanical skills in assembly and use of processing equipment and aides.
• Ability to interact effectively within all levels of the company.
• Self-starter with ability to adjust schedules in order to meet commitments.
• Excellent record-keeping and communication skills.
• Knowledge of job related regulatory requirements (cGMP, OSHA, and EPA).
• Must be able to pass a respirator fit test.