Chemical Operator I

Piramal Pharma Limited; Riverview, Northern (MI, KY); Hybrid; USD 48,000 - 60,000; Full time

Job summary

Piramal Pharma Solutions' HPAPI facility located in Riverview, Michigan, is seeking a qualified Chemical Operator I to join our Production team. The role involves conducting chemical syntheses of APIs and their intermediates in accordance with cGMP and SOPs to ensure quality and regulatory compliance.

The successful candidate will adhere to FDA, EPA, and OSHA requirements, maintain accurate records, and work with processing equipment.

Qualifications

• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA.
• Identify and protect original technical information as company property.
• Maintain alignment with PPS mission, vision, and values.

Responsibilities

• Conduct chemical syntheses of APIs and their intermediates within scheduled dates independently.
• Comply with all policies, procedures, and regulatory requirements.
• Maintain cleanliness and routine maintenance of the work area and equipment.
• Support inventory control of basic raw materials, consumables, and wastes.
• Document all work in required formats, including electronic systems.
• Assist in assembling and maintaining operation documents for regulatory compliance.
• Report needs, concerns, and problems to Supervisor promptly.

Skills

Mechanical skills

Regulatory knowledge

Documentation

Communication skills

Team collaboration

Education

High school diploma or equivalent

Two-year diploma preferred

Job description

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

Chemical Operator I

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.

Job Conditions

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Demands

Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected. Long periods of standing and walking can be expected in this position. This position may require long periods of sitting, typing, computer entry or looking at a computer.

Work Environment

Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes. Potential limited exposure to hazardous chemicals. Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.