Manufacturing Associate I

PSC Biotech.com

Office

York, United States

Full Time

BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

The Experience

With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

Your Role

This role is responsible for performing routine and critical manufacturing operations, including but not limited to work functions in aseptic and non-aseptic filling, equipment prep, cleaning dissolution and formulation activities, while ensuring compliance with current GMP/ISO standards as defined in FDA and EU regulations. Successful candidates will be motivated, proactive, with a strong drive to learn and passion for the life sciences.

Execute manufacturing instructions for equipment preparation, compounding, filtration, formulation, and fill activities for aseptic and terminally sterilized products in accordance with SOPs.
Adhere to verbal instructions and written procedures when operating production equipment and performing processing steps; accurately complete all required production documentation.
Ensure documentation (forms, logbooks, batch records, etc.) are complete, reviewed, and compliant with good documentation practices.
Identify, escalate, and document deviations from normal operations; participate in investigations as needed.
Assist in the introduction of manufacturing schemes into the GMP manufacturing facility.
Carry out all routine and critical operations, as well as commissioning and validation activities, as assigned.
Perform room sanitization activities to maintain controlled environment conditions.
Maintain general knowledge of aseptic techniques, retain certification for aseptic gowning, and demonstrate competence in performing duties with proper aseptic technique.
Perform and ensure completion of CIP (Clean-in-Place) and SIP (Steam-in-Place) operations to prepare equipment.
Support cross-functional operations by assisting engineering, warehouse, and facilities departments as required.
Additional responsibilities as assigned.

Requirements

Associate or Bachelor's Degree in Life Sciences, Technical Discipline, or Liberal Arts field with a minimum of at least 1 year of professional experience (preferably in an FDA regulated pharmaceutical facility). Or high school diploma with 2-3 years of relevant work experience in mechanically based or similar role.
Ability and willingness to work extended shifts and a variable schedule when required.
Experience in reviewing and creating controlled documents preferred.
Experience with sterile injectable drugs preferred.
Familiarity with formulation, filling, primary packaging, and aseptic processing preferred.
Strong knowledge of aseptic technique is preferred.
Flexible and adaptable.
Excellent communication skills, both verbal and written.
Proficient in MS Office/Excel.
Strong organizational and time management skills.
Self-motivated with the ability to complete multiple-floor activities in an effective and compliant manner.
Attention to detail with strong mechanical aptitude.
Positive attitude and excellent interpersonal skills.
Ability to plan and prioritize complex activities.
Strong analytical skills to identify risks and prepare balanced decisions.

Benefits

Offering a full suite of benefits, BioTechnique is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

Medical, Dental, and Vision - BioTechnique pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Fitness Benefits (membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
Financial Perks and Discounts

Equal Opportunity Employment Statement:
BioTechnique is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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